Product Code: KTT FDA class 2 21 CFR 888.3030

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Orthopedic

The Multiple Component Nail/Blade/Plate Combination Fixation Appliance is an orthopedic implant system composed of multiple assembled components used to internally fix fractures of the proximal femur and peritrochanteric region, providing structural support during bone healing. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KTT, regulated under 21 CFR 888.3030, in the Orthopedic medical specialty. This device is an implant.

View on FDA

510(k)s

404

FEI Numbers

249

Registration Numbers

249

Unique Applicants

154

Years Active

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Basic Information

Product Code: KTT
Device Class: FDA class 2
Regulation Number: 888.3030
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 404 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K254087	MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System	Jun 11, 2026	Substantially Equivalent	Synthes (USA) Products, LLC
K260900	DYNEX® External Fixation Systems	Apr 17, 2026	Substantially Equivalent	Vilex, LLC
K260112	QuikFix External Fixator: Knee-Spanning Pack	Mar 23, 2026	Substantially Equivalent	Stabiliz Orthopaedics, Inc.
K253291	Excelsior System	Jan 20, 2026	Substantially Equivalent	Blue Ocean Global
K253613	Monkey Rings External Ring Fixation System	Dec 19, 2025	Substantially Equivalent	Paragon 28, Inc.
K253202	Hoffmann LRF System	Dec 19, 2025	Substantially Equivalent	Stryker GmbH
K252555	Medusa Orthopedics Boa External Fixation System	Nov 25, 2025	Substantially Equivalent	Medusa Orthopedics, LLC
K252625	The Response Ortho Smart Fixator - Hexapod System	Nov 20, 2025	Substantially Equivalent	Response Ortho Solutions, LLC
K252106	External Fixation Mini Rail System	Sep 30, 2025	Substantially Equivalent	Paragon 28, Inc.
K251862	External Fixation Bone Distractor	Aug 11, 2025	Substantially Equivalent	Paragon 28, Inc.
K250472	SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)	Aug 08, 2025	Substantially Equivalent	Amdt Holdings, Inc.
K251128	Extremity Medical External Fixation System	May 07, 2025	Substantially Equivalent	Extremity Medical, LLC
K243798	Orthex External Fixation System	Mar 07, 2025	Substantially Equivalent	OrthoPediatrics Corp.
K241563	Extremity Medical External Fixation System	Feb 21, 2025	Substantially Equivalent	Extremity Medical, LLC
K242861	TrueLok Elevate	Dec 03, 2024	Substantially Equivalent	Orthofix Srl
K242452	Monkey Bars Pin to Bar External Fixation System	Nov 01, 2024	Substantially Equivalent	Paragon 28, Inc.
K241769	Response Ortho Metaphyseal Hinge Fixator System	Sep 18, 2024	Substantially Equivalent	Response Ortho Solutions, LLC
K233025	Revolution External Plating System	May 30, 2024	Substantially Equivalent	New Standard Device Dba Metalogix
K240049	LINK(TM) External Fixator	May 29, 2024	Substantially Equivalent	Metric Medical Devices, Inc.
K233741	Hoffmann LRF System	Dec 21, 2023	Substantially Equivalent	Stryker GmbH
K221787	Auxein's DHS/DCS Plate System	Nov 30, 2023	Substantially Equivalent	Auxein Medical Private Limited
K232897	Arthrex Small External Fixation System	Oct 18, 2023	Substantially Equivalent	Arthrex, Inc.
K232838	Monkey RingsTM External Fixation System	Oct 12, 2023	Substantially Equivalent	Paragon 28, Inc.
K231922	DEPUY SYNTHES MAXFRAME AUTOSTRUT System	Jul 26, 2023	Substantially Equivalent	DePuy Synthes
K231461	Smart Correction System (HA Half Pins)	Jun 16, 2023	Substantially Equivalent	Wishbone Medical, Inc.
K223786	Orthex External Fixation System	Feb 10, 2023	Substantially Equivalent	OrthoPediatrics Corp.
K213905	ONX Large External Fixation System	Aug 25, 2022	Substantially Equivalent	Orthonovis, Inc.
K221366	Smart Correction System Rings and Compatible HA-Coated Half Pins	Jun 06, 2022	Substantially Equivalent	Wishbone Medical, Inc.
K220809	Drive Rail System	Apr 08, 2022	Substantially Equivalent	OrthoPediatrics Corp.
K212895	Paragon 28 External Ring Fixation System	Nov 08, 2021	Substantially Equivalent	Paragon 28, Inc.
K212044	TrueLok Evo	Nov 05, 2021	Substantially Equivalent	Orthofix Srl
K212552	Correx Software	Oct 12, 2021	Substantially Equivalent	Vilex, LLC
K210953	SMART Taylor Spatial Frame	Jul 29, 2021	Substantially Equivalent	Smith & Nephew, Inc.
K211313	MAXFRAME Multi-Axial Correction System (aka MAXFRAME)	May 25, 2021	Substantially Equivalent	Synthes (USA) Products, LLC
K211112	OIC External Fixation System	May 05, 2021	Substantially Equivalent	Orthopaedic Implant Company
K203568	Hoffmann LRF System	Feb 01, 2021	Substantially Equivalent	Stryker GmbH
K202833	Sequel External Fixation Device	Jan 19, 2021	Substantially Equivalent	Sequel Medical, Inc.
K202810	AutoStrut G2	Jan 06, 2021	Substantially Equivalent	Orthospin, Ltd.
K200491	Bfix Orthopedic External Fixator Systems	Jan 05, 2021	Substantially Equivalent	Aike (Shanghai) Medical Instrument Co., Ltd.
K201253	Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation	Dec 08, 2020	Substantially Equivalent	Smith & Nephew
K202762	Circular Fixation with Balanced Cable Transport	Nov 16, 2020	Substantially Equivalent	Smith & Nephew, Inc.
K200728	Pitkar DeftFix System	Oct 06, 2020	Substantially Equivalent	S.H.Pitkar Orthotools Pvt. , Ltd.
K200123	Accessories for the SixFix® Hexapod Fixator	Sep 22, 2020	Substantially Equivalent	Arrowhead De, LLC
K193368	Smart Correction System	Sep 18, 2020	Substantially Equivalent	Wishbone Medical, Inc.
K200343	FusionFrame Ring Lock System	Sep 14, 2020	Substantially Equivalent	Glw Medical Innovation
K202143	Dynex Micro	Sep 11, 2020	Substantially Equivalent	Vilex, LLC
K202054	Dynex Ring Fixation System, Diametrix Ring Fixation System	Aug 24, 2020	Substantially Equivalent	Vilex, LLC
K200518	Pitkar External Fixation System - Rail Mechanism	Jul 29, 2020	Substantially Equivalent	S.H.Pitkar Orthotools Pvt. , Ltd.
K192181	PRECICE Plating System	Nov 07, 2019	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.
K190486	Pitkar External Fixation System	Oct 16, 2019	Substantially Equivalent	S.H.Pitkar Orthotools Pvt. , Ltd.
K191241	AutoStrut	Aug 14, 2019	Substantially Equivalent	Orthospin
K181630	Revolution External Plating System	May 29, 2019	Substantially Equivalent	New Standard Device Dba Metalogix
K190069	SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)	May 14, 2019	Substantially Equivalent	Arrowhead De, LLC
K183682	OIC External Fixation System	Apr 08, 2019	Substantially Equivalent	Orthopaedic Implant Company
K181528	Austin Miller Large External Fixation System	Feb 28, 2019	Substantially Equivalent	Austin Miller Trauma, LLC
K182968	Hoffmann LRF System	Jan 25, 2019	Substantially Equivalent	Stryker GmbH
K182154	Depuy Synthes Femoral Neck System	Oct 16, 2018	Substantially Equivalent	Synthes (USA) Products, LLC
K173883	External Fixation System	Sep 07, 2018	Substantially Equivalent	Life Spine, Inc.
K180580	Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices	Jul 27, 2018	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.
K180832	SALVATION External Fixation System	Jun 06, 2018	Substantially Equivalent	Wrightmedicaltechnologyinc
K172872	DePuy Synthes Femoral Neck System	Mar 05, 2018	Substantially Equivalent	DePuy Synthes
K172438	ARBOR External Fixation System	Jan 12, 2018	Substantially Equivalent	Globus Medical, Inc.
K171911	Medline ReNewal Reprocessed Synthes External Fixation Systems	Nov 09, 2017	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.
K170146	Galaxy UNYCO System	Oct 12, 2017	Substantially Equivalent	Orthofix Srl
K171211	OIC External Fixation System	Sep 27, 2017	Substantially Equivalent	Orthopaedic Implant Company
K170482	Spider Frame External Fixation System	Sep 27, 2017	Substantially Equivalent	Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S
K170704	The Locking Pediatric Osteotomy Plate (LolliPOP) System	Sep 08, 2017	Substantially Equivalent	Pega Medical, Inc.
K163486	DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Takú Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates	Jul 24, 2017	Substantially Equivalent	Hnm Total Recon, LLC
K170650	Orthofix TrueLok Hexapod System (TL-HEX) V2.0	May 10, 2017	Substantially Equivalent	Orthofix Srl
K163656	Hoffmann LRF System	Apr 14, 2017	Substantially Equivalent	Stryker GmbH
K163323	Dolphix® External Fixation System MR Conditional	Mar 20, 2017	Substantially Equivalent	Citieffe S.R.L.
K162033	SALVATION External Fixation System	Mar 06, 2017	Substantially Equivalent	Wright Medical
K162032	Arrowhead Mini-Rail Fixator	Feb 21, 2017	Substantially Equivalent	Arrowhead De, LLC
K160972	Gexfix External Fixation	Dec 28, 2016	Substantially Equivalent	Gexfix International Corp.
K161753	Hoffman LRF System	Nov 15, 2016	Substantially Equivalent	Stryker GmbH
K161417	DePuy Synthes MAXFRAME Multi-Axial Correction System	Nov 10, 2016	Substantially Equivalent	Synthes USA, LLC
K160830	Integra External Fixation System	Jul 06, 2016	Substantially Equivalent	Ascension Orthopedics
K153377	Hoffmann LRF (Limb Reconstruction Frame) System	Apr 11, 2016	Substantially Equivalent	Stryker GmbH
K151881	X-Fix Line Additions	Mar 24, 2016	Substantially Equivalent	Vilex IN Tennessee, Inc.
K151580	D.N.E. External Fixation System	Feb 16, 2016	Substantially Equivalent	Dne, LLC
K153635	SALVATION(R) External Fixation System	Jan 13, 2016	Substantially Equivalent	Wrightmedicaltechnologyinc
K153415	Reprocessed Stryker External Fixation Devices	Jan 13, 2016	Substantially Equivalent	Stryker Sustainability Solutions
K153233	Galaxy UNYCO System	Jan 06, 2016	Substantially Equivalent	Orthofix Srl
K151907	Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables	Dec 30, 2015	Substantially Equivalent	Zimmer, Inc.
K152755	FastFrame External Fixation System-Ankle Spanning	Dec 21, 2015	Substantially Equivalent	Zimmer, Inc.
K152484	FastFrame External Fixation System - Distal Radius	Dec 04, 2015	Substantially Equivalent	Zimmer, Inc.
K150640	RX-FIX Mini Rail External Fixator	Dec 01, 2015	Substantially Equivalent	Wrightmedicaltechnologyinc
K151992	FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control	Nov 02, 2015	Substantially Equivalent	Zimmer, Inc.
K152171	Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4	Sep 28, 2015	Substantially Equivalent	Orthofix Srl
K152158	ARIX Ankle System	Sep 28, 2015	Substantially Equivalent	Jeil Medical Corporation
K152045	SALVATION® External Fixation System	Aug 21, 2015	Substantially Equivalent	Wrightmedicaltechnologyinc
K150818	Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System	May 01, 2015	Substantially Equivalent	Zimmer, Inc.
K150579	Cardinal Health External Fixation System	Apr 29, 2015	Substantially Equivalent	Cardinalhealth
K150004	SALVATION External Fixation System	Mar 04, 2015	Substantially Equivalent	Wrightmedicaltechnologyinc
K143220	SIDEKICK EZ FRAME External Fixation System	Jan 08, 2015	Substantially Equivalent	Wrightmedicaltechnologyinc
K143125	Orthofix True Lok Hexapod System VI.3	Dec 10, 2014	Substantially Equivalent	Orthofix Srl
K141760	ORTHOFIX GALAXY WRIST	Dec 08, 2014	Substantially Equivalent	Orthofix Srl
K142052	ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT	Dec 05, 2014	Substantially Equivalent	Orthofix Srl
K142520	Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software	Nov 20, 2014	Substantially Equivalent	Smith & Nephew, Inc.
K140961	HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM	Nov 10, 2014	Substantially Equivalent	Stryker Trauma AG
K141912	AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON	Oct 29, 2014	Substantially Equivalent	Advanced Orthopaedic Solutions, Inc.
K140463	INTEGRA EXTERNAL FIXATION SYSTEM	Oct 10, 2014	Substantially Equivalent	Ascension Orthopedic
K141697	XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM	Sep 18, 2014	Substantially Equivalent	Zimmer, Inc.
K141078	ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX)	Sep 02, 2014	Substantially Equivalent	Orthofix Srl
K140675	EMERGE EXTERNAL FIXATION SYSTEM	Jun 10, 2014	Substantially Equivalent	Emerge Medical, Inc.
K140822	DRIVE RAIL SYSTEM	May 29, 2014	Substantially Equivalent	Devise Ortho, Inc.
K140158	S.E.A.L. FRACTURE FUSION TUBE	May 29, 2014	Substantially Equivalent	Dne, LLC
K131413	XTRAFIX SMALL EXTERNAL FIXATION SYSTEM	Jan 28, 2014	Substantially Equivalent	Zimmer, Inc.
K132363	DOLPHIX EXTERNAL FIXATION SYSTEM	Jan 16, 2014	Substantially Equivalent	Citieffe S.R.L.
K130907	HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM	Jun 10, 2013	Substantially Equivalent	Stryker Trauma AG
K122777	NBX - NON BRIDGING EXTERNAL FIXATOR HAND	May 15, 2013	Substantially Equivalent	Nutek Orthopaedics, Inc.
K130479	ILIZAROV DRILL TIP WIRES	May 14, 2013	Substantially Equivalent	Smith & Nephew, Inc.
K130334	HOFFMANN LRF (LIMB RECONSTRUCTION FRAME SYSTEM)	May 03, 2013	Substantially Equivalent	Stryker Trauma AG
K122210	NEWFIX EXTERNAL FIXATION SYSTEM	Apr 19, 2013	Substantially Equivalent	Tecnologia Y Diseno Industrial, S.A DE C.V
K122455	SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM	Apr 11, 2013	Substantially Equivalent	Synthes
K130044	SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM	Apr 05, 2013	Substantially Equivalent	Wrightmedicaltechnologyinc
K122284	HOFFMANN 3	Oct 24, 2012	Substantially Equivalent	Stryker Corp.
K113770	ORTHOFIX GALAXY FIXATION SYSTEM	Sep 04, 2012	Substantially Equivalent	Orthofix Srl
K121252	HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM	Jul 25, 2012	Substantially Equivalent	Stryker Corp.
K113383	XTRAFIX EXTERNAL FIXATION SYSTEM	Jun 26, 2012	Substantially Equivalent	Extraortho, Inc.
K113384	EXTERNAL FIXATOR ST.A R 90 F4	May 01, 2012	Substantially Equivalent	Citieffe
K113327	HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM	Mar 29, 2012	Substantially Equivalent	Stryker Corp.
K111786	HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM	Jan 26, 2012	Substantially Equivalent	Stryker Corp.
K113123	OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM	Jan 12, 2012	Substantially Equivalent	The Orthopaedic Implant Company
K113106	DNE EXTERNAL FIXATION SYSTEM	Jan 04, 2012	Substantially Equivalent	Dne, LLC
K112218	ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS	Dec 15, 2011	Substantially Equivalent	DePuy Orthopaedics, Inc.
K110426	DYNA-EXTOR II	Nov 02, 2011	Substantially Equivalent	Bk Meditech, Co., Ltd.
K111993	FRAMEWALKER	Oct 24, 2011	Substantially Equivalent	Quantum Medical Concepts, LLC
K111155	XTRAFIX EXTERNAL FIXATION SYSTEM	Oct 20, 2011	Substantially Equivalent	Extraortho, Inc.
K111376	CONSTRUX EXTERNAL FIXATION DEVICE	Aug 03, 2011	Substantially Equivalent	Ebi, LLC
K110965	RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM	May 11, 2011	Substantially Equivalent	Renovis Surgical Technologies, LLC
K102843	MAC MALE ADAPTER	May 03, 2011	Substantially Equivalent	Biomet Trauma (Aka Ebi, LLC)
K103015	ODRC-DYNAMIC HIP SCREW SYSTEM	Apr 13, 2011	Substantially Equivalent	Orthopaedic Device Research Center
K101338	NEWFIX EXTERNAL FIXATION SYSTEM	Mar 14, 2011	Substantially Equivalent	Technologia Y Diseno Industrial, S.A DE C.V
K110069	SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE	Feb 08, 2011	Substantially Equivalent	Smith & Nephew, Inc.
K102057	TARGON FN SYSTEM	Dec 21, 2010	Substantially Equivalent	Aesculap Implant Systems, LLC
K102688	MERETE LOCKING BONE PLATE SYSTEM II	Dec 03, 2010	Substantially Equivalent	Merete Medical GmbH
K101759	QUANTUM RING FIXATION SYSTEM MODEL ISF	Oct 22, 2010	Substantially Equivalent	Quantum Medical Concepts, LLC
K093047	SMITH & NEPHEW CIRCULAR FIXATION SYSTEM	Sep 27, 2010	Substantially Equivalent	Smith & Nephew, Inc.
K101170	ACUTE INNOVATIONS STERNAL FIXATION SYSTEM	Sep 17, 2010	Substantially Equivalent	Acute Innovations, LLC
K100795	JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING	Sep 02, 2010	Substantially Equivalent	Smith & Nephew, Inc.
K093753	MDPO FRAME SYSTEM	Aug 26, 2010	Substantially Equivalent	Mdpo, LLC
K100137	SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES	Jun 10, 2010	Substantially Equivalent	Wrightmedicaltechnologyinc
K100857	FUSION MEDICAL RING LOCK SYSTEM	May 27, 2010	Substantially Equivalent	John J Riccio
K092190	SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS	May 11, 2010	Substantially Equivalent	Synthes (Usa)
K090658	SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL	Mar 03, 2010	Substantially Equivalent	Synthes (Usa)
K093550	MINI RAIL EXTERNAL FIXATOR SYSTEM	Jan 07, 2010	Substantially Equivalent	Small Bone Innovations, Inc.
K092002	AFGHAN EXTERNAL FIXATOR	Dec 10, 2009	Substantially Equivalent	Smith & Nephew, Inc.
K093057	BIOMET VISION FOOTRING SYSTEM	Dec 01, 2009	Substantially Equivalent	Ebi, L.P.
K092834	HOFFMAN XPRESS LINE EXTENSION	Oct 08, 2009	Substantially Equivalent	Howmedica Osteonics Corp.
K091619	ANGLEFIX T LOCKING PLATE, MODELS AF-001 (PLATE), ST-1 (LOCKING SCREW)	Sep 08, 2009	Substantially Equivalent	Anglefix
K083582	SIGN HIP CONSTRUCT (SHC), MODEL: 701	Aug 26, 2009	Substantially Equivalent	Surgical Implant Generation Network (Sign)
K091258	EXTRAFIX EXTERNAL FIXATION SYSTEM	Jul 24, 2009	Substantially Equivalent	Qfx Technologies, Inc.
K090926	SMITH & NEPHEW RAIL SYSTEM	Jun 08, 2009	Substantially Equivalent	Smith & Nephew, Inc.
K090063	MERETE LOCKING BONE PLATE SYSTEM	Apr 22, 2009	Substantially Equivalent	Merete Medical, Inc.
K083789	ACE FISCHER EXTERNAL FIXATION SYSTEM	Mar 23, 2009	Substantially Equivalent	DePuy Orthopaedics, Inc.
K083636	REPROCESSED EXTERNAL FIXATION DEVICE	Mar 02, 2009	Substantially Equivalent	Sterilmed, Inc.
K082833	NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER	Feb 05, 2009	Substantially Equivalent	Nutek Orthopaedics, Inc.
K082650	SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL	Nov 18, 2008	Substantially Equivalent	Synthes (Usa)
K081586	REPROCESSED EXTERNAL FIXATION DEVICE	Aug 18, 2008	Substantially Equivalent	Sterilmed, Inc.
K081342	REPROCESSED EXTERNAL FIXATION ACCESSORIES	Aug 13, 2008	Substantially Equivalent	Sterilmed, Inc.
K081244	LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS	Jul 30, 2008	Substantially Equivalent	Biomet Trauma
K081284	VARIAX DISTAL FIBULA PLATE	Jul 18, 2008	Substantially Equivalent	Howmedica Osteonics Corp.
K081278	OMEGA 3 TROCHANTERIC STABILIZING PLATE	May 29, 2008	Substantially Equivalent	Howmedica Osteonics Corp.
K080408	EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD	Apr 25, 2008	Substantially Equivalent	Advanced Orthopaedic Solutions, Inc.
K072212	JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE	Mar 07, 2008	Substantially Equivalent	Smith & Nephew, Inc.
K073076	HOFFMANN LIGHT SYSTEM	Feb 15, 2008	Substantially Equivalent	Howmedica Osteonics Corp.
K073527	VARIAX ELBOW SYSTEM	Feb 14, 2008	Substantially Equivalent	Howmedica Osteonics Corp.
K080071	SIDEKICK RAIL FIXATOR	Feb 07, 2008	Substantially Equivalent	Wrightmedicaltechnologyinc
K072250	SUPERCABLE GRIP AND PLATE SYSTEM	Nov 09, 2007	Substantially Equivalent	Kinamed, Inc.
K071852	AAP APS SYSTEM	Aug 29, 2007	Substantially Equivalent	Aap Implantate AG
K071395	BIOMET VISION FOOTRING SYSTEM	Jul 09, 2007	Substantially Equivalent	Biomet Manufacturing Corp
K071394	MODIFICATION TO:SBI RINGFIX	Jun 29, 2007	Substantially Equivalent	Small Bone Innovations, Inc.
K070724	IOS EXTERNAL FIXATOR, MODEL 2-0-0	May 16, 2007	Substantially Equivalent	Intelligent Orthopaedics, Ltd.
K070454	OMEGA 3 SUPRACONDYLAR PLATE	Apr 12, 2007	Substantially Equivalent	Howmedica Osteonics Corp.
K070016	BLUE SHARK	Apr 02, 2007	Substantially Equivalent	Meridan Medical
K063487	MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE	Jan 22, 2007	Substantially Equivalent	Merete Medical GmbH
K063509	DEPUY PEAK FX HIP PLATE	Jan 04, 2007	Substantially Equivalent	DePuy Orthopaedics, Inc.
K063551	AEQUALIS HUMERAL PLATE	Dec 22, 2006	Substantially Equivalent	Tornier
K061759	REPROCESSED EXTERNAL FIXATION DEVICE	Sep 05, 2006	Substantially Equivalent	Ascent Healthcare Solutions
K062066	OMEGA 3 SYSTEM	Aug 15, 2006	Substantially Equivalent	Howmedica Osteonics Corp.
K061748	FRAGMENT PLATE SYSTEM	Jul 17, 2006	Substantially Equivalent	Hand Innovations, LLC
K060613	VARIAX LOCKING PLATE SYSTEM	Apr 21, 2006	Substantially Equivalent	Howmedica Osteonics Corp.
K060545	UNITY HUMERAL PLATE	Apr 21, 2006	Substantially Equivalent	Tornier
K052918	REPROCESSED EXTERNAL FIXATION DEVICES	Jan 27, 2006	Substantially Equivalent	Alliance Medical Corp.
K053472	HOFFMANN II MRI EXTERNAL FIXATION SYSTEM	Jan 11, 2006	Substantially Equivalent	Howmedica Osteonics Corp.
K053051	VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES	Dec 22, 2005	Substantially Equivalent	Vanguard Medical Concepts, Inc.
K053349	HOFFMANN II ROD TO WIRE COUPLING	Dec 09, 2005	Substantially Equivalent	Howmedica Osteonics Corp.
K053038	HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM	Nov 22, 2005	Substantially Equivalent	Howmedica Osteonics Corp.
K052196	VILEX X-FIX	Nov 22, 2005	Substantially Equivalent	Vilex, Inc.
K052605	EXTERNAL FIXATION	Nov 10, 2005	Substantially Equivalent	Gexfix USA, Inc.
K052498	FRAGMENT SPECIFIC FIXATOR	Oct 17, 2005	Substantially Equivalent	David J. Slutsky MD
K052239	EBI DYNAFIX VISION FOOTPLATE SYSTEM	Sep 21, 2005	Substantially Equivalent	Ebi, L.P.
K051957	REPROCESSED EXTERNAL FIXATION DEVICE	Sep 21, 2005	Substantially Equivalent	Sterilemed, Inc.
K052005	R&R EXTERNAL FIXATION SYSTEM	Sep 06, 2005	Substantially Equivalent	R&R Medical, Inc.
K051616	VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES	Sep 06, 2005	Substantially Equivalent	Vanguard Medical Concepts, Inc.
K052064	ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES	Aug 25, 2005	Substantially Equivalent	Alliance Medical Corp.
K052062	ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES	Aug 25, 2005	Substantially Equivalent	Alliance Medical Corp.
K052065	ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES	Aug 22, 2005	Substantially Equivalent	Alliance Medical Corp.
K052037	MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM	Aug 05, 2005	Substantially Equivalent	Howmedica Osteonics Corp.
K051600	SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM	Jul 27, 2005	Substantially Equivalent	Synthes (Usa)
K051180	VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES	Jul 22, 2005	Substantially Equivalent	Vanguard Medical Concepts, Inc.
K051162	GENEROS SB SMALL BONE DISTRACTION IMPLANT	Jul 19, 2005	Substantially Equivalent	Orthonetx, Inc.
K051049	SYNTHES (USA) LOW-PROFILE WRIST FIXATOR	Jul 13, 2005	Substantially Equivalent	Synthes (Usa)
K051554	ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES	Jun 29, 2005	Substantially Equivalent	Alliance Medical Corp.
K051017	R-X-FIX EXTERNAL FIXATOR	Jun 29, 2005	Substantially Equivalent	R-X-Fix
K050849	HA COATED LAG SCREW	May 04, 2005	Substantially Equivalent	Smith & Nephew, Inc.
K050457	MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM	Mar 14, 2005	Substantially Equivalent	Merete Medical GmbH
K050048	HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM	Mar 04, 2005	Substantially Equivalent	Howmedica Osteonics Corp.
K043289	E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT	Feb 11, 2005	Substantially Equivalent	Signal Medical Corp.
K043174	STEALTH FUSION SYSTEM, MODEL RR 1000	Feb 07, 2005	Substantially Equivalent	R&R Medical, Inc.
K043113	TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE	Jan 21, 2005	Substantially Equivalent	DePuy Orthopaedics, Inc.
K043039	SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE	Jan 18, 2005	Substantially Equivalent	Synthes (Usa)
K033856	5.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN	Jan 07, 2005	Substantially Equivalent	Peter Stevens, MD
K042761	WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES	Nov 17, 2004	Substantially Equivalent	Zimmer, Inc.
K042895	SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES	Nov 16, 2004	Substantially Equivalent	Synthes (Usa)
K042436	IIIZAROV PULLEY SYSTEM	Oct 07, 2004	Substantially Equivalent	Smith & Nephew, Inc.
K042358	LOCON VLS DISTAL RADIUS PLATE SYSTEM	Oct 07, 2004	Substantially Equivalent	Wrightmedicaltechnologyinc
K042312	JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/MR SAFE	Sep 24, 2004	Substantially Equivalent	Smith & Nephew, Inc.
K042019	HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM	Sep 24, 2004	Substantially Equivalent	Howmedica Osteonics Corp.
K041911	SYNTHES (USA) LCP CURVED PLATES	Sep 08, 2004	Substantially Equivalent	Synthes (Usa)
K041709	NUMELOCK II SYSTEM	Sep 08, 2004	Substantially Equivalent	Howmedica Osteonics Corp.
K041706	HOFFMANN II FOOT RING	Sep 08, 2004	Substantially Equivalent	Howmedica Osteonics Corp.
K040935	EBI XFIX DFS SYSTEM	Jul 06, 2004	Substantially Equivalent	Ebi, L.P.
K041081	FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES	Jul 01, 2004	Substantially Equivalent	Hand Innovations, Inc.
K041001	OMEGA 2 SYSTEM	Jul 01, 2004	Substantially Equivalent	Howmedica Osteonics Corp.
K031687	VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES	Apr 30, 2004	Substantially Equivalent	Vanguard Medical Concepts, Inc.
K040833	MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM	Apr 29, 2004	Substantially Equivalent	Ebi, L.P.
K040258	SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE	Mar 23, 2004	Substantially Equivalent	Synthes (Usa)
K040064	NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR	Mar 23, 2004	Substantially Equivalent	Newmedical Technology, Inc.
K033995	3.5 MM LCP DISTAL HUMERUS SYSTEM	Mar 01, 2004	Substantially Equivalent	Synthes (Usa)
K033476	MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM	Jan 20, 2004	Substantially Equivalent	Howmedica Osteonics Corp.
K033556	SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM	Jan 13, 2004	Substantially Equivalent	Synthes (Usa)
K033763	MODIFICATION TO SLIM GLIDING NAIL SYSTEM	Dec 18, 2003	Substantially Equivalent	Plus Orthopedics
K033635	MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM	Dec 03, 2003	Substantially Equivalent	Ebi, L.P.
K033411	SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS	Nov 26, 2003	Substantially Equivalent	Synthes (Usa)
K033158	SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES	Nov 05, 2003	Substantially Equivalent	Synthes (Usa)
K033112	WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS	Nov 05, 2003	Substantially Equivalent	Hand Biomechanics Lab, Inc.
K031875	INTER-OS LIMB LENGTHENER	Oct 22, 2003	Substantially Equivalent	Inter-Os Technologies
K031919	EBI XFIX DFS SYSTEM	Sep 04, 2003	Substantially Equivalent	Ebi, L.P.
K031401	FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS)	Aug 06, 2003	Substantially Equivalent	Disco-O-Tech Medical Technologies, Ltd.
K032058	MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES	Jul 30, 2003	Substantially Equivalent	Alliance Medical Corp.
K031724	SYNTHES SMALL COBINATION CLAMP-MR SAFE	Jul 14, 2003	Substantially Equivalent	Synthes (Usa)
K031181	EXTERNAL FIXATION SYSTEMS	Jul 14, 2003	Substantially Equivalent	Smith & Nephew, Inc.
K031093	EBI XFIX OPTIROM KNEE FIXATOR	Jul 10, 2003	Substantially Equivalent	Ebi, L.P.
K031645	EBI XFIX DFS SYSTEM	Jun 25, 2003	Substantially Equivalent	Ebi, L.P.
K031725	SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM	Jun 24, 2003	Substantially Equivalent	Synthes (Usa)
K031573	SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE	Jun 06, 2003	Substantially Equivalent	Synthes (Usa)
K030372	MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM	Mar 06, 2003	Substantially Equivalent	Ebi, L.P.
K023714	REPROCESSED EXTERNAL FIXATION DEVICE	Feb 03, 2003	Substantially Equivalent	Alliance Medical Corp.
K023851	PRECIMED HIP SCREW SYSTEM	Jan 28, 2003	Substantially Equivalent	Precimed, Inc.
K023941	SYNTHES TOMOFIX OSTEOTOMY SYSTEM	Jan 23, 2003	Substantially Equivalent	Synthes (Usa)
K024248	MODIFICATION TO EBI XFIX DFS SYSTEM METAPHYSEAL CORRECTION SYSTEM	Jan 22, 2003	Substantially Equivalent	Ebi, L.P.
K024129	MODIFICATION TO EBI XFIX DFS SYSTEM	Jan 15, 2003	Substantially Equivalent	Ebi, L.P.
K023399	EBI XFIX DFS SYSTEM	Oct 25, 2002	Substantially Equivalent	Ebi, L.P.
K023324	MODIFICATION TO EBI XFIX DFS SYSTEM	Oct 18, 2002	Substantially Equivalent	Ebi, L.P.
K023314	MICROFIX	Oct 18, 2002	Substantially Equivalent	Fixano SA
K022771	TWIN FIX	Sep 23, 2002	Substantially Equivalent	Fixano SA
K022423	EXTERNAL FIXATION RING	Sep 17, 2002	Substantially Equivalent	Rigid FX Orthopedics, Incorporated
K021933	TEMPFIX EXTERNAL FIXATION SYSTEM	Aug 26, 2002	Substantially Equivalent	DePuy Orthopaedics, Inc.
K022319	EBI XFIX DFS SYSTEM	Aug 12, 2002	Substantially Equivalent	Ebi, L.P.
K012648	REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES	Jun 24, 2002	Substantially Equivalent	Alliance Medical Corp.
K012623	REPROCESSED EXTERNAL FIXATION DEVICE	Jun 24, 2002	Substantially Equivalent	Alliance Medical Corp.
K021695	EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM	Jun 20, 2002	Substantially Equivalent	Ebi, L.P.
K020772	OMEGA II SYSTEM	Jun 05, 2002	Substantially Equivalent	Howmedica Osteonics Corp.
K021312	EBI DFS OPTIROM ELBOW FIXATOR	May 23, 2002	Substantially Equivalent	Ebi, L.P.
K021031	EBI XFIX RAIL SYSTEM	May 16, 2002	Substantially Equivalent	Ebi, L.P.
K021091	EBI XFIX DFS SYSTEM	May 03, 2002	Substantially Equivalent	Ebi, L.P.
K020311	CLEARVIEW WRIST FIXATOR	Apr 29, 2002	Substantially Equivalent	Rigid FX Orthopedics, Incorporated
K020403	MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR	Mar 08, 2002	Substantially Equivalent	Ebi, L.P.
K012294	WRISTORE FIXATOR	Mar 04, 2002	Substantially Equivalent	Millennium Medical Technologies, Inc.
K014276	MODIFICATION TO EBI XFIX DFS SYSTEM	Mar 01, 2002	Substantially Equivalent	Ebi, L.P.
K020240	SLIM GLIDING NAIL SYSTEM	Feb 22, 2002	Substantially Equivalent	Plus Orthopedics
K020141	MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM	Feb 05, 2002	Substantially Equivalent	Ebi, L.P.
K014194	MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM	Jan 17, 2002	Substantially Equivalent	Ebi, L.P.
K013540	EBI XFIX ACCESS PELVIC FIXATOR	Nov 20, 2001	Substantially Equivalent	Ebi, L.P.
K013503	MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR	Nov 16, 2001	Substantially Equivalent	DePuy Orthopaedics, Inc.
K013378	EBI XFIX DFS SYSTEM	Nov 08, 2001	Substantially Equivalent	Ebi, L.P.
K012078	RADIOFIX	Sep 27, 2001	Substantially Equivalent	Fixano SA
K012062	PF2	Sep 27, 2001	Substantially Equivalent	Fixano SA
K011603	VHS PEDIATRIC HIP SCREW SYSTEM	Aug 15, 2001	Substantially Equivalent	Walter Abendschein, M.D.
K012024	EBI XFIX DFS SYSTEM	Jul 25, 2001	Substantially Equivalent	Ebi, L.P.
K011711	MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM	Jun 29, 2001	Substantially Equivalent	Ebi, L.P.
K011697	EBI XFIX ACCESS PELVIC FIXATOR	Jun 27, 2001	Substantially Equivalent	Ebi, L.P.
K011034	SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM	Jun 27, 2001	Substantially Equivalent	Synthes (Usa)
K010766	SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE	Jun 12, 2001	Substantially Equivalent	Synthes (Usa)
K010518	SYNTHES ANTEROLATERAL CALCANEAL PLATE	May 23, 2001	Substantially Equivalent	Synthes (Usa)
K010344	ADJUSTABLE LARGE FIXATOR SYSTEM	May 03, 2001	Substantially Equivalent	Synthes (Usa)
K010437	MODIFICATION TO EBI XFIX DFS RAIL SYSTEM	Mar 13, 2001	Substantially Equivalent	Ebi, L.P.
K003397	COLLES C SERIES FRAME STERILE PACK	Jan 29, 2001	Substantially Equivalent	DePuy Orthopaedics, Inc.
K001358	EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM	May 23, 2000	Substantially Equivalent	Ebi, L.P.
K000734	PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601	May 05, 2000	Substantially Equivalent	Pioneer Surgical Technology
K000682	SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM	May 01, 2000	Substantially Equivalent	Synthes (Usa)
K000684	SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM	Apr 28, 2000	Substantially Equivalent	Synthes (Usa)
K000319	EBI XFIX DFS SYSTEM	Feb 25, 2000	Substantially Equivalent	Ebi, L.P.
K000083	EBI XFIX DFS RAIL SYSTEM	Feb 03, 2000	Substantially Equivalent	Ebi, L.P.
K993873	ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD	Jan 03, 2000	Substantially Equivalent	Alphatec Mfg., Inc.
K993289	SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM	Dec 20, 1999	Substantially Equivalent	Smith & Nephew, Inc.
K993886	EBI XFIX VISION FIXATION SYSTEM	Dec 14, 1999	Substantially Equivalent	Ebi, L.P.
K993649	EBI XFIX DFS WRISTFIX SYSTEM	Nov 19, 1999	Substantially Equivalent	Ebi, L.P.
K991941	EBI XFIX DFS RAIL SYSTEM	Aug 19, 1999	Substantially Equivalent	Electro-Biology, Inc.
K992515	EBI XFIX DFS OPTIROM ELBOW FIXATOR	Aug 17, 1999	Substantially Equivalent	Ebi, L.P.
K991806	VHS SUPRACONDYLAR PLATE SYSTEM	Aug 06, 1999	Substantially Equivalent	Walter Abendschein, M.D.
K984364	SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820	Mar 02, 1999	Substantially Equivalent	Syntec Scientific Corp.
K984498	SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM	Feb 18, 1999	Substantially Equivalent	Synthes (Usa)
K983873	SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM	Dec 30, 1998	Substantially Equivalent	Syntec Scientific Corp.
K981483	EBI DFS JOINT FIXATOR, MODEL 02800	Jul 08, 1998	Substantially Equivalent	Electro-Biology, Inc.
K980370	BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR	Apr 14, 1998	Substantially Equivalent	Biomet, Inc.
K974409	FRIEDL GLIDING NAIL SYSTEM	Feb 19, 1998	Substantially Equivalent	Plus Orthopedics
K974537	SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM	Feb 18, 1998	Substantially Equivalent	Synthes (Usa)
K973321	HOFFMANN II COMPACT PERIARTICULAR CLAMP	Nov 20, 1997	Substantially Equivalent	Howmedica, Inc.
K973231	THE CORIFIX DYNAMIC HIP SCREW SYSTEM	Nov 20, 1997	Substantially Equivalent	Corin USA
K971993	ODI COMPRESSION HIP SCREW SYSTEM	Nov 12, 1997	Substantially Equivalent	Orthopaedic Designs, Inc.
K973017	SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP	Oct 16, 1997	Substantially Equivalent	Synthes (Usa)
K964880	VARI-ANGLE HIP SCREW (VHS) SYSTEM	Oct 16, 1997	Substantially Equivalent	Walter Abendschein, M.D.
K972629	DEPUY AE TK2 HIP SCREW SYSTEM	Oct 09, 1997	Substantially Equivalent	Depuy, Inc.
K970748	TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM	May 09, 1997	Substantially Equivalent	Smith & Nephew, Inc., Orthopaedic Div.
K964400	ALPHATEC EXTERNAL FIXATION SYSTEM	Apr 28, 1997	Substantially Equivalent	Alphatec Mfg., Inc.
K970290	EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM	Apr 01, 1997	Substantially Equivalent	Ebi, L.P.
K962251	MEDOFF SLIDING PLATE (PROPOSED NAME)	Jan 22, 1997	Substantially Equivalent	Wrightmedicaltechnologyinc
K964458	ELLIS EXTERNAL MINI-FIXATOR SYSTEM	Dec 09, 1996	Substantially Equivalent	Link America, Inc.
K964094	MINIFIX	Nov 27, 1996	Substantially Equivalent	Ferguson Medical
K962484	SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC)	Sep 05, 1996	Substantially Equivalent	Synthes (Usa)
K962808	ILIZAROV EXTERNAL FIXATION SYSTEM	Aug 19, 1996	Substantially Equivalent	Smith & Nephew Richards, Inc.
K961433	EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS	Jun 28, 1996	Substantially Equivalent for Some Indications	Electro-Biology, Inc.
K961350	SYNTHES MINI EXTERNAL FIXATOR	Jun 28, 1996	Substantially Equivalent	Synthes (Usa)
K961213	ALTA DOME AND PLUNGER (MEC HIP BOLT)	Jun 13, 1996	Substantially Equivalent	Howmedica Corp.
K955306	OMEGA+ COMPRESSION SCREW SYSTEM	Apr 10, 1996	Substantially Equivalent	Howmedica Corp.
K960014	PRACTIFIX EXTERNAL FIXATION SYSTEM	Mar 18, 1996	Substantially Equivalent	Orthopaedic Innovations, Inc.
K954555	VERSA-FX FEMORAL FIXATION SYSTEM	Jan 26, 1996	Substantially Equivalent	Zimmer, Inc.
K954712	INTRAMEDULLARY HIP SCREW (MODIFICATION)	Oct 31, 1995	Substantially Equivalent	Smith & Nephew Richards, Inc.
K953406	EBI X FIX DYNAFIX SYSTEM (DFS)	Oct 31, 1995	Substantially Equivalent	Electro-Biology, Inc.
K951809	GLIDING NAIL	Jul 13, 1995	Substantially Equivalent	Encore Orthopedics, Inc.
K951357	EBI SMALL EXTERNAL FIXATOR (S/E/F/)	Jun 21, 1995	Substantially Equivalent for Some Indications	Electro-Biology, Inc.
K946156	DEPUY COMPRESSION HIP SCREW SYSTEM	May 03, 1995	Substantially Equivalent for Some Indications	Depuy, Inc.
K945233	PEDIATRIC OSTEOTOMY SYSTEM	Feb 01, 1995	Substantially Equivalent	Howmedica Corp.
K930836	HOWMEDICA(R) MONO-TUBE(TM) EXTERNAL FIXATOR SYSTEM	Jan 18, 1995	Substantially Equivalent	Howmedica Corp.
K944883	GAMMA LOCKING NAIL - LONG LENGTH	Nov 28, 1994	Substantially Equivalent	Howmedica Corp.
K926417	ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREW	Sep 28, 1994	Substantially Equivalent	Alphatec Mfg., Inc.
K940286	GAMMA LOCKING NAIL MODIFICATION	Mar 14, 1994	Substantially Equivalent	Howmedica, Inc.
K925460	SYNTHES STERILE PINLESS EXTERNAL FIXATOR	Mar 10, 1994	Substantially Equivalent	Synthes (Usa)
K932174	GAMMA LOCKING NAIL-CROSS LOCKING SCREWS	Mar 07, 1994	Substantially Equivalent	Howmedica Corp.
K930156	MEGA PLUS SUPER LAG SCREW	Feb 22, 1994	Substantially Equivalent	Pfizer Hospital Products Group, Inc.
K923032	FIXEL EXTERNAL FIXATION DEVICE	Oct 04, 1993	Substantially Equivalent	Amp, Inc.
K915599	CAP WASHER ASSEMBLY	Oct 01, 1993	Substantially Equivalent	Howmedica Corp.
K925127	ALTA CANCELLOUS BONE SCREW	Mar 22, 1993	Substantially Equivalent	Howmedica Corp.
K910993	MORREY ELBOW FIXATOR	Nov 25, 1992	Substantially Equivalent	Howmedica Corp.
K922295	OMEGA PLUS COMPRESS HIP SCREW SYSTEM, MODIFICATION	Sep 08, 1992	Substantially Equivalent	Howmedica Corp.
K921786	INTRAMEDULLARY HIP SCREW	Jul 17, 1992	Substantially Equivalent	Smith & Nephew Richards, Inc.
K910483	MONOTUBE EXTERNAL FIXATION SYSTEM	Jul 14, 1992	Substantially Equivalent	Howmedica Corp.
K920608	AMERICA SYSTEM	Jun 19, 1992	Substantially Equivalent	I. Klimov Co.
K920024	RIHARDS TITANIUM HALF PIN	Jan 21, 1992	Substantially Equivalent	Smith & Nephew Richards, Inc.
K914558	TRAUMAFIX (TM) EXTERNAL FIXATOR	Jan 16, 1992	Substantially Equivalent	Synthes (Usa)
K910986	HOFFMANN DYNAMIC WRIST FIXATOR	Jan 16, 1992	Substantially Equivalent	Howmedica Corp.
K912162	INTRAMEDULLARY HIP SCREW, MODIFICATION	Aug 14, 1991	Substantially Equivalent	Smith & Nephew Richards, Inc.
K911021	PLATE BLADE WITH CURSOR OF L'UNION	May 29, 1991	Substantially Equivalent	Sport Service, Inc.
K905514	AUTOGENESIS(TM) AUTOMATOR	Apr 02, 1991	Substantially Equivalent	Advanced Biosearch Assn.
K904973	EXTERNAL FIXATION	Feb 21, 1991	Substantially Equivalent	Dynasplint Systems, Inc.
K905352	BLADE PLATE	Dec 11, 1990	Substantially Equivalent	O'Tec Corp.
K905346	JEWETT HIP NAIL	Dec 11, 1990	Substantially Equivalent	O'Tec Corp.
K905342	LAG SCREW	Dec 11, 1990	Substantially Equivalent	O'Tec Corp.
K905338	SIDE PLATE	Dec 11, 1990	Substantially Equivalent	O'Tec Corp.
K901234	KIRSCHNER BLADE PLATE SYSTEM OR R.A.B. BLADE PLATE	Oct 04, 1990	Substantially Equivalent	Kirschner Medical Corp.
K903251	JEWETT HIP NAIL	Jul 30, 1990	Substantially Equivalent	Onyx Medical Corp.
K903250	BLADE PLATE	Jul 30, 1990	Substantially Equivalent	Onyx Medical Corp.
K903246	SIDE PLATE	Jul 30, 1990	Substantially Equivalent	Onyx Medical Corp.
K901525	K-CAPE ORTHOPEDIC WIRES AND PINS	Apr 23, 1990	Substantially Equivalent	Westcon Orthopedics, Inc.
K901272	ORION BLADE PLATE FOR TIBIAL OSTEOTOMY	Apr 23, 1990	Substantially Equivalent	Med-Tek Corp.
K900584	ALTA LAG SCREW AND COMPRESSION SCREW	Apr 18, 1990	Substantially Equivalent	Howmedica Corp.
K890989	DR. HERZBERG DISPOSABLE EXTERNAL FIXATOR	Apr 05, 1990	Substantially Equivalent for Some Indications	Origin Medsystems, Inc.
K895507	LINK GIEBEL BLADE PLATE SYSTEM	Mar 13, 1990	Substantially Equivalent	Link America, Inc.
K895241	INTRAMEDULLARY HIP SCREW	Jan 04, 1990	Substantially Equivalent	Richards Medical Co., Inc.
K891066	DANEK WRIST FIXATOR	Aug 28, 1989	Substantially Equivalent	Danek Medical, Inc.
K893639	GAMMA LOCKING NAIL	Aug 03, 1989	Substantially Equivalent	Howmedica Corp.
K890814	DANEK RING FIXATOR (DRF)	Jun 13, 1989	Substantially Equivalent	Danek Medical, Inc.
K883715	AXIAL COMPRESSION SCREW	Sep 22, 1988	Substantially Equivalent	Straub Clinic and Hospital
K882922	TECHMEDICA MP SYSTEM	Sep 22, 1988	Substantially Equivalent	Techmedica, Inc.
K873459	ALTA SYSTEMS TIBIAL/UPPER EXTREMITY DIAPHYSEAL PLT	Oct 28, 1987	Substantially Equivalent	Howmedica Corp.
K872224	MODIFIED TROCHANTER CABLE GRIP SYSTEM	Aug 17, 1987	Substantially Equivalent	Howmedica Corp.
K872223	MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM	Jun 26, 1987	Substantially Equivalent	Howmedica Corp.
K871248	KRONNER COLLES-FOREARM EXTERNAL FIXATION	Jun 03, 1987	Substantially Equivalent	Kronner Medical
K870786	AXIAL COMPRESSION SCREW	Jun 01, 1987	Substantially Equivalent	Straub Clinic and Hospital
K871249	KRONNER BI-PLANER TIBIA EXTERNAL FIXATION	May 22, 1987	Substantially Equivalent	Kronner Medical
K871247	KRONNER UNIVERSAL FRAME EXTERNAL FIXATION	May 22, 1987	Substantially Equivalent	Kronner Medical
K870961	RICHARDS EXTERNAL FIXATION SYSTEM	Mar 19, 1987	Substantially Equivalent	Richards Medical Co., Inc.
K863343	SUPERFIXATION(TM)	Sep 15, 1986	Substantially Equivalent	Orthopaedic Device Corp.
K862311	SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN	Jul 25, 1986	Substantially Equivalent	Warsaw Orthopedic, Inc.
K861178	DEPUY COMPRESSION HIP SCREW SYSTEM	Apr 15, 1986	Substantially Equivalent	Depuy, Inc.
K854205	KIRSCHNER COMPRESSION HIP SCREW SYSTEM	Nov 19, 1985	Substantially Equivalent	Kirschner Medical Corp.
K850443	MEC ROD CONNECTOR	Jul 15, 1985	Substantially Equivalent	Pfizer, Inc.
K850413	MEC HIP BOLT	Jul 15, 1985	Substantially Equivalent	Pfizer, Inc.
K850403	MEC DISTAL FEMORAL BOLT	Jul 15, 1985	Substantially Equivalent	Pfizer, Inc.
K851919	SUPRACONDYLAR BONE PLATE	Jun 28, 1985	Substantially Equivalent	Warsaw Orthopedic, Inc.
K844068	TROCHANTER CABLE GRIP SYSTEM	Jun 21, 1985	Substantially Equivalent	Howmedica Corp.
K843449	AUTODYNAMIC COMPRESSION HIP SCREW-PLATE	Oct 22, 1984	Substantially Equivalent	Mecron Medical Products, Inc.
K842695	T.O.D. PLATE SYS STERILE	Sep 25, 1984	Substantially Equivalent	Kirschner Medical Corp.
K842681	T.O.D. PLATE SYSTEM	Sep 25, 1984	Substantially Equivalent	Kirschner Medical Corp.
K842768	ACE/FISHER EXTERNAL FIXATOR	Sep 21, 1984	Substantially Equivalent	Buckman Co., Inc.
K830196	CORSTREN COMPRESSION TUBE & PLATE	Mar 25, 1983	Substantially Equivalent	Zimmer, Inc.
K823548	COMPRESSION HIP SCREW SIDE-PLATE	Dec 28, 1982	Substantially Equivalent	Howmedica Corp.
K813554	ACE/KYLE CAPTURED HIP SCREW	Jan 12, 1982	Substantially Equivalent	Ace Orthopedic Manufacturing Co.
K811017	HUCKSTEP INTRAMEDULLARY NAIL	May 27, 1981	Substantially Equivalent	Downs Surgical , Ltd.
K791619	DYNAMIC HIP SCREW	Aug 28, 1979	Substantially Equivalent	Synthes (Usa)
K790501	PEDIATRIC OSTEOTOMY SYSTEM	Apr 10, 1979	Substantially Equivalent	Howmedica Corp.