Product Code: JDR FDA class 2 21 CFR 888.3030

Staple, Fixation, Bone

Orthopedic

The Bone Fixation Staple is an orthopedic implant used to stabilize fractures, osteotomies, or bony fusions by spanning a fracture line or joint and holding bone segments in close apposition. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and compliance with general and special controls. The product code is JDR, regulated under 21 CFR 888.3030, within the Orthopedic medical specialty. This device carries the implant flag, indicating it is surgically placed and remains within the body.

View on FDA

510(k)s

231

FEI Numbers

245

Registration Numbers

245

Unique Applicants

124

Years Active

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Basic Information

Product Code: JDR
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 231 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250712	Linkt Compression Staple System	May 14, 2025	Substantially Equivalent	Trax Surgical
K243888	Medline UNITE® REFLEX® Hybrid Nitinol Implant System	Apr 11, 2025	Substantially Equivalent	Medline Industries, LP
K243742	Arthrex DynaNite Nitinol Staples	Jan 31, 2025	Substantially Equivalent	Arthrex, Inc.
K243658	TMC Compression Implant System	Dec 26, 2024	Substantially Equivalent	Treace Medical Concepts
K242415	TMC Compression Implant System	Sep 06, 2024	Substantially Equivalent	Treace Medical Concepts
K240212	COGNiTiON Staple System	Feb 23, 2024	Substantially Equivalent	Ortho Solutions UK , Ltd.
K232990	ATOMIC Nitinol Fixation System	Jan 12, 2024	Substantially Equivalent	Rmr Ortho, LLC
K230724	arcad® 2.0 Duo & Quadro osteosynthesis compressive staples	Dec 04, 2023	Substantially Equivalent	Novastep
K232905	Medline UNITE® REFLEX® Nitinol Staple Kit	Oct 19, 2023	Substantially Equivalent	Medline Industries, LP
K232324	StealthFix Intraosseous Fixation System	Aug 30, 2023	Substantially Equivalent	Medartis, Inc.
K232387	Treace Medical Concepts (TMC) Compression Implant System	Aug 28, 2023	Substantially Equivalent	Treace Medical Concepts
K231493	NITINEX Memory Compression Staple	Aug 11, 2023	Substantially Equivalent	Vilex, LLC
K231885	Medline UNITE® REFLEX® Nitinol Staple System	Aug 09, 2023	Substantially Equivalent	Medline Industries, LP
K231458	Extremity Staple	Aug 03, 2023	Substantially Equivalent	Restor3D
K230550	JAWS Nitinol Staple System	May 11, 2023	Substantially Equivalent	Paragon 28, Inc.
K223056	JAWS Nitinol Staple System	Feb 16, 2023	Substantially Equivalent	Paragon 28, Inc.
K222645	Treace Medical Concepts (TMC) Implant Fixation System	Nov 21, 2022	Substantially Equivalent	Treace Medical Concepts
K221947	Tyber Medical Staple Fixation System (various)	Oct 20, 2022	Substantially Equivalent	Tyber Medical, LLC
K220812	DynaClip® Bone Staple	Aug 19, 2022	Substantially Equivalent	MedShape, Inc.
K210582	EasyClip® and EasyClip® Xpress	Jun 10, 2022	Substantially Equivalent	Stryker GmbH
K220181	StealthFix Intraosseous Fixation System	Mar 22, 2022	Substantially Equivalent	Nextremity Solutions, Inc.
K203832	FuseForce Flex Dynamic Compression System	May 07, 2021	Substantially Equivalent	Wright Medical
K210482	Medline UNITE REFLEX Nitinol Staple System	Apr 22, 2021	Substantially Equivalent	Medline Industries, Inc.
K210456	Ligament Staple	Apr 12, 2021	Substantially Equivalent	Medacta International S.A.
K203180	Arthrex DynaNite Nitinol Staples	Dec 16, 2020	Substantially Equivalent	Arthrex, Inc.
K193305	DynaClip Bone Staple	Apr 23, 2020	Substantially Equivalent	MedShape, Inc.
K192447	Superelastic Staple	Feb 28, 2020	Substantially Equivalent	Neosteo
K191463	DePuy Synthes Hammertoe Continuous Compression Implant	Feb 26, 2020	Substantially Equivalent	Synthes (USA) Products, LLC
K191636	APTUS Foot System	Aug 16, 2019	Substantially Equivalent	Medartis AG
K190722	TriMAX Implant System	Aug 16, 2019	Substantially Equivalent	Crossroads Extemity Systems, LLC
K190166	TriMed Nitinol Staple System	Jul 01, 2019	Substantially Equivalent	TriMed, Inc.
K182943	VERTEX Nitinol Staple System	Apr 04, 2019	Substantially Equivalent	Nvision Biomedical Technologies, LLC
K182212	Geo Staple System	Jan 11, 2019	Substantially Equivalent	Gramercy Extremity Orthopedics, LLC
K181781	DynaClipTM Bone Staple	Nov 05, 2018	Substantially Equivalent	MedShape, Inc.
K181815	DynaBridge	Oct 15, 2018	Substantially Equivalent	Fusion Orthopedics, LLC
K181866	MotoCLIP/HiMAX Step Staple Implant System	Aug 09, 2018	Substantially Equivalent	Crossroads Extremity Systems, LLC
K180544	DePuy Synthes Static Staples	Jul 24, 2018	Substantially Equivalent	Synthes (USA) Products, LLC
K181410	MotoCLIP/HiMAX Implant System	Jun 29, 2018	Substantially Equivalent	Crossroads Extremity Systems, LLC
K173775	Clench Compression Staple	Apr 06, 2018	Substantially Equivalent	F & A Foundation, LLC D.B.A. Reign Medical
K173693	Orbitum Bone Staple Implant, X and VI	Feb 23, 2018	Substantially Equivalent	Orthovestments, LLC
K172205	ExoToe Staple	Jan 11, 2018	Substantially Equivalent	Exotoe, LLC
K172052	Arthrex DynaNite Nitinol Staple	Dec 13, 2017	Substantially Equivalent	Arthrex, Inc.
K172405	SNIPER STAPLE SYSTEM, NON-STERILE	Dec 11, 2017	Substantially Equivalent	Trilliant Surgical
K171473	Compressyn Staple	Nov 07, 2017	Substantially Equivalent	Dallen Medical, Inc.
K170923	JAWS(TM) Nitinol Staple System	Jul 24, 2017	Substantially Equivalent	Paragon 28
K163226	EPIC Extremely Small Staple	May 16, 2017	Substantially Equivalent	Epic Extremely, LLC
K162354	Sniper Staple System	Apr 20, 2017	Substantially Equivalent	Trilliant Surgical, Ltd.
K162321	EasyClip Xpress	Feb 10, 2017	Substantially Equivalent	Restore Surgical, LLC Dba Instratek
K163440	Stealth Staple System	Feb 01, 2017	Substantially Equivalent	First Ray, LLC
K161587	Memodyn Staple	Feb 01, 2017	Substantially Equivalent	Austin & Associates, Inc./Telos Medical Equipment
K161426	NeoSpan Compression Staple Impant w/instruments	Oct 24, 2016	Substantially Equivalent	In2bones USA, LLC
K160813	EasyStep	Jul 26, 2016	Substantially Equivalent	Stryker GmbH
K153622	First Ray Internal Bone Staple System	Apr 08, 2016	Substantially Equivalent	First Ray, LLC
K153770	OS2(R)-VP Varisation Staple	Mar 21, 2016	Substantially Equivalent	In2bones Sas
K153395	OS2-C Compression Staple	Feb 18, 2016	Substantially Equivalent	In2bones Sas
K153129	dynaMX Tabbed Staple	Jan 28, 2016	Substantially Equivalent	Mx Orthopedics, Corp.
K151762	PediatrOS RigidTack/FlexTack	Dec 28, 2015	Substantially Equivalent	Merete Medical GmbH
K151615	TiTHON Staple with OsseoTi Technology	Oct 02, 2015	Substantially Equivalent	Biomet Manufacturing Corp
K151160	Arcus Staple System	Sep 04, 2015	Substantially Equivalent	Nextremity Solutions, Inc.
K143622	dynaMX Compression Staple	Jun 17, 2015	Substantially Equivalent	Mx Orthopedics, Corp.
K150125	Elite Nitinol Fixation System	May 11, 2015	Substantially Equivalent	Biomedical Enterprises, Inc.
K143323	OS2-V Varisation Staple	Feb 26, 2015	Substantially Equivalent	In2bones Sas
K143037	SnapShot Fixation System	Jan 20, 2015	Substantially Equivalent	Biomet Manufacturing Corp
K142111	ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE	Dec 19, 2014	Substantially Equivalent	Novatsep
K141263	TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS	Nov 19, 2014	Substantially Equivalent	Biomet Manufacturing Corp
K142292	Speed, Speed Shift, Speed Titan, Speed Arc	Nov 17, 2014	Substantially Equivalent	Biomedical Enterprises, Inc.
K142727	CrossCLIP Implant System	Oct 24, 2014	Substantially Equivalent	Orthodiscovery Group, LLC(D.B.A. Crossroads Extremity Systems
K142148	ORTHOHELIX STAPLE SYSTEM	Aug 21, 2014	Substantially Equivalent	Orthohelix Surgical Designs, Inc.
K141550	INSTAFIX SHAPE MEMORY FIXATION SYSTEM	Jul 11, 2014	Substantially Equivalent	Ot Medical
K140358	COMPRESSYN STAPLE	Jun 02, 2014	Substantially Equivalent	Dallen Medical, Inc.
K133270	SPEED ARC	Apr 17, 2014	Substantially Equivalent	Biomedical Enterprises, Inc.
K133844	SPEED TRIAD	Apr 07, 2014	Substantially Equivalent	Biomedical Ent., Inc.
K133780	SPEED XL	Mar 19, 2014	Substantially Equivalent	Biomedical Ent., Inc.
K133523	STAPIX SUPERELASTIC IMPLANT BONE STAPLES	Feb 06, 2014	Substantially Equivalent	Instratek, Inc.
K132875	COMPRESSYN STAPLE	Dec 30, 2013	Substantially Equivalent	Dallen Medical, Inc.
K131061	RESTORE BUNION CORRECTION SYSTEM	Aug 28, 2013	Substantially Equivalent	Nextremity Solutions
K130832	ORTHOHELIX STAPLE SYSTEM	Aug 15, 2013	Substantially Equivalent	Orthohelix Surgical Designs, Inc.
K124045	FUSEFORCE IMPLANT SYSTEM	Jul 10, 2013	Substantially Equivalent	Solana Surgical, LLC
K124022	SPEED SHIFT	May 14, 2013	Substantially Equivalent	Biomedical Enterprises, Inc.
K123926	METASURG NITINOL STAPLE IMPLANT	May 03, 2013	Substantially Equivalent	Metasurg
K122113	MEMORY METAL STAPLES, EASYCLIP	Mar 12, 2013	Substantially Equivalent	Stryker Corp.
K122871	COMPRESSYN STAPLE	Feb 07, 2013	Substantially Equivalent	Dallen Medical, Inc.
K123363	SUPER STAPLE(TM) CLASSIC	Jan 03, 2013	Substantially Equivalent	Metric Medical Devices, Inc.
K112837	VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)	Oct 09, 2012	Substantially Equivalent	Vilex, Inc.
K102387	MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES	Oct 24, 2011	Substantially Equivalent	Mediscope Manufacturing, Inc.
K102143	SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM	Dec 08, 2010	Substantially Equivalent	Suspension Orthopaedic Solutions, LLC
K102107	OSSTAPLE CHILL	Sep 03, 2010	Substantially Equivalent	Biomedical Ent., Inc.
K082215	OSTEORAPTOR SUTURE ANCHOR	Nov 03, 2008	Substantially Equivalent	Smith & Nephew Inc., Endoscopy Division
K081172	COMPOSITE HITCH SUTURE ANCHOR	Jul 17, 2008	Substantially Equivalent	Biomet Manufacturing Corp
K081098	ENDOBUTTON CONTINUOUS LOOP (CL)	Jul 16, 2008	Substantially Equivalent	Smith & Nephew Inc., Endoscopy Division
K073281	CAIS STAPLE	May 02, 2008	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K080111	ARTHREX COMPRESSION STAPLE	Feb 13, 2008	Substantially Equivalent	Arthrex, Inc.
K072298	BIOPRO MEMORY STAPLE, MODELS 18062-18073	Oct 29, 2007	Substantially Equivalent	Biopro, Inc.
K071477	REVERTO 55 AND 37 SHAPE MEMORY STAPLES	Aug 15, 2007	Substantially Equivalent	Core Essence Orthopaedics, LLC
K071637	INTRINSIC THERAPEUTICS FIXATION STAPLE	Aug 03, 2007	Substantially Equivalent	Intrinsic Therapeutics Incorporated
K071479	SBI STAFIX	Aug 02, 2007	Substantially Equivalent	Small Bone Innovations, Inc.
K071257	MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD	Jun 29, 2007	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K070688	NEXFIX COMPRESSION STAPLE	May 18, 2007	Substantially Equivalent	Nexa Orthopedics, Inc.
K070033	MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10	Mar 19, 2007	Substantially Equivalent	Memometal Technologies
K070031	MEMOMETAL MEMORY STAPLES	Mar 19, 2007	Substantially Equivalent	Memometal Technologies
K063273	PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR	Nov 22, 2006	Substantially Equivalent	Depuy Miltek, A Johnson & Johnson Co.
K062734	ADJUST-RIGHT FIXATION DEVICES	Nov 22, 2006	Substantially Equivalent	Valpo Orthopedic Technology, Inc.
K061776	ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE	Sep 25, 2006	Substantially Equivalent	Arthrotek, Inc.
K062170	BIOKNOTLESS AND LUPINE PLUS ANCHORS	Aug 22, 2006	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K061798	BIOPRO MEMORY STAPLE	Aug 21, 2006	Substantially Equivalent	Biopro, Inc.
K061801	2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS	Aug 07, 2006	Substantially Equivalent	Arthrotek, Inc.
K061657	HITCH LACTOSORB SUTURE ANCHOR	Jul 25, 2006	Substantially Equivalent	Arthrotek, Inc.
K061389	ALLTHREAD LACTOSORB SUTURE ANCHOR	Jul 19, 2006	Substantially Equivalent	Arthrotek, Inc.
K060970	AXYALOOP NONABSORBABLE BONE ANCHOR	Jul 05, 2006	Substantially Equivalent	Axya Medical, Inc.
K061594	LARGE UNI-CLIP STAPLE	Jul 03, 2006	Substantially Equivalent	New Deal, S.A.
K060746	MEMORY STAPLE	May 25, 2006	Substantially Equivalent	DePuy Orthopaedics, Inc.
K060553	RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP W/PANACRYL SUTURE	May 04, 2006	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K060014	INTELIFUSE, INC., WARMSYSTEM WITH STIMULINKS	Apr 03, 2006	Substantially Equivalent	Intelifuse, Inc.
K052631	SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)	Oct 21, 2005	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K051989	GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE	Aug 05, 2005	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K051408	INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS	Jun 29, 2005	Substantially Equivalent	Intelifuse, Inc.
K043059	COMPRESSION STAPLE AND SIMPLE STAPLE	Jan 18, 2005	Substantially Equivalent	Wrightmedicaltechnologyinc
K041988	ARTHROTEK MENISCAL HYBRID DEVICE	Oct 20, 2004	Substantially Equivalent	Biomet, Inc.
K041117	PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732	May 28, 2004	Substantially Equivalent	Depuy Mitek
K041116	SUPER QUICKANCHOR PLUS	May 28, 2004	Substantially Equivalent	Depuy Mitek
K041115	GII QUICKANCHOR PLUS	May 28, 2004	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K041064	BIOKNOTLESS RC ANCHOR	May 13, 2004	Substantially Equivalent	Depuy Mitek
K041065	PANALOK RC LOOP ANCHOR	May 07, 2004	Substantially Equivalent	Depuy Mitek
K031127	ORTHOPEDIC WIRE	Apr 28, 2003	Substantially Equivalent	Howmedica Osteonics Corp.
K023388	MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM	Dec 27, 2002	Substantially Equivalent	Mitek Worldwide
K021953	MITEK PDS/PGA STAPLE	Dec 20, 2002	Substantially Equivalent	Mitek Worldwide
K023417	SURETAC III, MODELS 7209900, 7209901	Nov 07, 2002	Substantially Equivalent	Smith & Nephew, Inc.
K023203	OSSTAPLE	Oct 17, 2002	Substantially Equivalent	Biomedical Ent., Inc.
K020948	SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II	Oct 09, 2002	Substantially Equivalent	Smith & Nephew, Inc.
K012081	DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM	Oct 01, 2001	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K011716	THE UNI-CLIP STAPLE	Aug 30, 2001	Substantially Equivalent	New Deal, S.A.
K010051	POLY-TAPES WITH THE FASTLOK FIXATION DEVICE	Jul 13, 2001	Substantially Equivalent	Xiros Plc
K002695	MEMODYN STAPLE	Jun 13, 2001	Substantially Equivalent	Telos Medical Equipment
K003033	SCAPHIX, STAPLE, FIXATION, BONE	May 30, 2001	Substantially Equivalent	Avanta Orthopaedics, Inc.
K001354	MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM	Mar 13, 2001	Substantially Equivalent	Biomedical Ent., Inc.
K000797	OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01	Apr 03, 2000	Substantially Equivalent	Orthopaedic Biosystems, Ltd.
K993714	MEMOGRAPH STAPLE, WARM SYSTEM	Feb 25, 2000	Substantially Equivalent	Biomedical Ent., Inc.
K991962	EIS DYNAMIC MEMORY STAPLES SYSTEM	Jan 10, 2000	Substantially Equivalent	Groupe Lepine
K991566	SOLUSTAPLE	Aug 03, 1999	Substantially Equivalent	New Deal, S.A.
K991482	UNI-CLIP STAPLE	Jun 03, 1999	Substantially Equivalent	New Deal, S.A.
K982996	POLYMER OBL SB ANCHOR / SUTURE COMBINATION	Mar 04, 1999	Substantially Equivalent	Orthopaedic Biosystems, Ltd.
K982420	MITEK MICRO ANCHOR	Aug 24, 1998	Substantially Equivalent	Mitek Products
K981798	LACTOSORB POP RIVET	Jul 13, 1998	Substantially Equivalent	Biomet, Inc.
K964226	MEMORY STAPLE (20 SIZES AVAILABLE)	Aug 05, 1997	Substantially Equivalent	Landos, Inc.
K965175	HOWMEDICA MAINSTAY ANCHOR	Mar 13, 1997	Substantially Equivalent	Howmedica Corp.
K962793	MITEK MICRO ANCHOR	Oct 01, 1996	Substantially Equivalent	Mitek Products
K962705	MLI MODULAR STAPLE	Oct 01, 1996	Substantially Equivalent	Medicinelodge, Inc.
K961585	SURGICAL DYNAMICS POP RIVET	Jul 10, 1996	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K961578	SUTURE ANCHOR	Jul 10, 1996	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K961555	ACUFEX TAG BIOABSORBABLE ANCHORS	Jul 10, 1996	Substantially Equivalent	Acufex Microsurgical, Inc.
K954443	LACTOSORB SUTURE ANCHOR	Jan 31, 1996	Substantially Equivalent for Some Indications	Poly-Medics,Inc.
K950272	PANALOK ABSORBABLE SUTURE ANCHOR SYSTEM	Jan 18, 1996	Substantially Equivalent for Some Indications	ETHICON, Inc.
K953276	ACUFEX TAG DELIVERY SYSTEM	Oct 05, 1995	Substantially Equivalent	Acufex Microsurgical, Inc.
K953531	HOWMEDICA MAINSTAY ANCHOR	Sep 26, 1995	Substantially Equivalent for Some Indications	Howmedica Corp.
K953764	LMT BONE ANCHOR	Aug 25, 1995	Substantially Equivalent	Li Medical Technologies, Inc.
K942889	SB ANCHOR	Aug 25, 1995	Substantially Equivalent	Orthopaedic Biosystems, Ltd.
K952348	OGDEN ANCHOR	Aug 21, 1995	Substantially Equivalent	American Medical Electronics, Inc.
K941772	CRADLE FIXATION DEVICE	Aug 07, 1995	Substantially Equivalent	Neoligaments, Ltd.
K951658	LACTOSORB POP RIVET	Jul 25, 1995	Substantially Equivalent for Some Indications	Poly-Medics,Inc.
K943950	ETHICON NONABSORBABLE SUTURE ANCHOR	May 30, 1995	Substantially Equivalent for Some Indications	ETHICON, Inc.
K950070	MITEK TOGGLE ANCHOR(TM)	May 22, 1995	Substantially Equivalent	Mitek Surgical Products, Inc.
K946346	ACUFEX TAG(R) BIOABSORBABLE ANCHORS	Apr 26, 1995	Substantially Equivalent	Acufex Microsurgical, Inc.
K944936	MITEK G III ANCHOR, MITEK LS ANCHOR	Mar 24, 1995	Substantially Equivalent	Mitek Surgical Products, Inc.
K943548	BIOABSORBABLE INTERFERENCE SCREW	Mar 20, 1995	Substantially Equivalent	Acufex Microsurgical, Inc.
K945203	MITEK THRADED ANCHOR (MTA)	Mar 06, 1995	Substantially Equivalent	Mitek Surgical Products, Inc.
K941029	OGDEN ANCHOR-SMALL (TENTATIVE)	Feb 09, 1995	Substantially Equivalent	American Medical Electronics, Inc.
K934867	ACUFEX TAG ANCHOR	Feb 09, 1995	Substantially Equivalent	Acufex Microsurgical, Inc.
K943492	ARTHREX STAPLES	Feb 01, 1995	Substantially Equivalent for Some Indications	Arthrex, Inc.
K935065	OGDEN ANCHOR ADDITIONAL APPLICATIONS	Jan 30, 1995	Substantially Equivalent	American Medical Electronics, Inc.
K942787	BONE ANCHOR	Dec 15, 1994	Substantially Equivalent	Acu Med, Inc.
K935321	INNOVASIVE SUTURE BONE FASTENER WITH SUTURE	Oct 19, 1994	Substantially Equivalent	Innovasive Devices, Inc.
K932041	XANCHOR SUTURE ATTACHMENT DEVICE	Aug 12, 1994	Substantially Equivalent for Some Indications	Orthopaedic Biosystems
K931782	MITEK GIII ANCHOR	Jul 22, 1994	Substantially Equivalent for Some Indications	Mitek Surgical Products, Inc.
K935167	OGDEN ANCHOR (MODIFICATION)	Jul 12, 1994	Substantially Equivalent for Some Indications	American Medical Electronics, Inc.
K931519	ACUFEX SURETAC	Jun 16, 1994	Substantially Equivalent	Acufex Microsurgical, Inc.
K931253	QUICKANCHOR II	Jun 16, 1994	Substantially Equivalent	Mitek Surgical Products, Inc.
K932925	BONE ANCHOR FOR SOFT TISSUE ATTACHMENT	Apr 26, 1994	Substantially Equivalent	Vesitec Medical, Inc.
K930967	BAUMER STAPLES	Mar 07, 1994	Substantially Equivalent	Baumer Ortopedia , Ltd.
K930892	MITEK MINI ANCHOR, MODIFICATION	Jan 07, 1994	Substantially Equivalent	Mitek Surgical Products, Inc.
K930893	MITEK SUPER QUICKANCHOR, MODIFICATION	Dec 08, 1993	Substantially Equivalent	Mitek Surgical Products, Inc.
K926384	STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE	Nov 16, 1993	Substantially Equivalent	Zimmer, Inc.
K926270	MITEK LIGAMENT ANCHOR	Oct 22, 1993	Substantially Equivalent	Mitek Surgical Products, Inc.
K930538	ACUFEX SURETAC(R) PAC	Sep 13, 1993	Substantially Equivalent	Acufex Microsurgical, Inc.
K924034	MINVASIVE SUTURE BONE FASTENER	Aug 24, 1993	Substantially Equivalent	Innovasive Devices, Inc.
K924367	OGDEN ANCHOR	Jul 26, 1993	Substantially Equivalent	Advanced Surgical Implants, Inc.
K911293	ACUFEX(R) TAG(TM)	Jul 21, 1993	Substantially Equivalent	Acufex Microsurgical, Inc.
K931182	VESITEC DRILL GUIDE	Jun 09, 1993	Substantially Equivalent	Vesitec Medical, Inc.
K924941	CONCEPT 4MM CANCELLOUS SCREW WITH EYELET	Jun 04, 1993	Substantially Equivalent	Linvatec Corp.
K926037	HARPOON SUTURE ANCHOR	May 05, 1993	Substantially Equivalent	Biomet, Inc.
K924665	QUICKANCHOR	Oct 27, 1992	Substantially Equivalent	Mitek Surgical Products, Inc.
K915889	MITEK BONE ANCHOR, MODIFICATION	Oct 22, 1992	Substantially Equivalent	Mitek Surgical Products, Inc.
K921873	QUICKANCHOR, MODIFICATION	Jun 09, 1992	Substantially Equivalent	Mitek Surgical Products, Inc.
K920213	MITEK ANCHOR, MITEK ANCHOR II	May 01, 1992	Substantially Equivalent	Mitek Surgical Products, Inc.
K911837	SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE	Nov 15, 1991	Substantially Equivalent	Acufex Microsurgical, Inc.
K913461	FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEM	Oct 15, 1991	Substantially Equivalent	Neoligaments, Ltd.
K911445	FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM	Jun 28, 1991	Substantially Equivalent	Neoligaments, Ltd.
K911031	THE TRAMOND PIN	May 29, 1991	Substantially Equivalent	Sport Service, Inc.
K911026	STAPLE BLADE FOR TIBIAL OSTEO/STAPLE BLADE L'UNION	May 29, 1991	Substantially Equivalent	Sport Service, Inc.
K911020	LIGAMENTOPLASTIC STAPLE OF L'UNION	May 29, 1991	Substantially Equivalent	Sport Service, Inc.
K910723	BIODEGRADABLE SURGICAL STAPLE	Mar 12, 1991	Substantially Equivalent	Instrument Makar, Inc.
K905112	SNAP-PAK (TM)	Jan 04, 1991	Substantially Equivalent	Mitek Surgical Products, Inc.
K904553	BONE STAPLE(S)	Dec 21, 1990	Substantially Equivalent	Synthes (Usa)
K905364	ROUND STAPLE	Dec 11, 1990	Substantially Equivalent	O'Tec Corp.
K905363	FIXATION STAPLE	Dec 11, 1990	Substantially Equivalent	O'Tec Corp.
K905362	BARBED SQUARE STAPLE	Dec 11, 1990	Substantially Equivalent	O'Tec Corp.
K904340	FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM	Oct 19, 1990	Substantially Equivalent	Neoligaments, Ltd.
K903022	FIXATION STAPLE	Aug 09, 1990	Substantially Equivalent	Onyx Medical Corp.
K903273	BARBED SQUARE STAPLE	Jul 30, 1990	Substantially Equivalent	Onyx Medical Corp.
K903271	ROUND STAPLE	Jul 30, 1990	Substantially Equivalent	Onyx Medical Corp.
K902751	MITEK ANCHOR II	Jul 24, 1990	Substantially Equivalent	Mitek Surgical Products, Inc.
K896471	TENSTAPLE ORTHOPEDIC STAPLING SYSTEM	Jul 24, 1990	Substantially Equivalent	Tenstaple, Inc.
K902567	STAPLE, SERRATED, FIXATION W/SPIKES, VARIOUS SIZES	Jul 10, 1990	Substantially Equivalent	A. Henniss
K895117	HTO COMPRESSING STAPLE	May 09, 1990	Substantially Equivalent	Howmedica Corp.
K897155	MITEK ANCHOR(TM)	Apr 04, 1990	Substantially Equivalent	Mitek Surgical Products, Inc.
K893203	BONE SCREW	Apr 04, 1990	Substantially Equivalent	Karlin Technology, Inc.
K892126	MITEK ANCHOR	Sep 19, 1989	Substantially Equivalent	Mitek Surgical Products, Inc.
K894929	STAPLE FIXATION SYSTEM	Aug 30, 1989	Substantially Equivalent	Concept, Inc.
K890962	ORTHOPAEDIC STAPLES	May 15, 1989	Substantially Equivalent	Ortho Spectrum, Inc.
K874914	ORTHOMET ORTHOPEDIC STAPLES	Feb 04, 1988	Substantially Equivalent	Orthomet, Inc.
K873507	LINK (R) AMERICAN-TYPE BONE STAPLE SYSTEM	Sep 16, 1987	Substantially Equivalent	Link America, Inc.
K861137	ORTHOMED ORTHOPAEDIC FIXATION STAPLES	Apr 17, 1986	Substantially Equivalent	Biomedical Exports, Inc.
K853704	LINK DYNAMIC STAPLE	Jan 21, 1986	Substantially Equivalent	Link America, Inc.
K854445	KIRSCHNER BONE FIXATION FASTENER SYSTEM	Nov 19, 1985	Substantially Equivalent	Kirschner Medical Corp.
K853267	DAY STAPLE	Sep 06, 1985	Substantially Equivalent for Some Indications	Protek, Inc.
K840566	BONE STAPLING FIXATION SYS	Nov 23, 1984	Substantially Equivalent	3M Company
K832884	FIXATION STAPLE DRIVER/EXTRACTOR	Oct 20, 1983	Substantially Equivalent	Warsaw Orthopedic, Inc.
K830455	STAPLES DESIGNED FOR ARTHROSCOPIC SURG	Mar 09, 1983	Substantially Equivalent	Instrument Makar, Inc.
K822943	ELLISON VITALLIUM FIXATION STAPLE SYS	Oct 27, 1982	Substantially Equivalent	Howmedica Corp.
K813567	TECHMEDIA BONE STAPLE	Jan 12, 1982	Substantially Equivalent	Techmedica, Inc.
K811500	COLBALT ALLOY ORTHOPAEDIC WIRE	Jun 18, 1981	Substantially Equivalent	Osteonics Corp.
K792204	HOWMEDICA COMPRESSION STAPLE SYSTEM	Dec 05, 1979	Substantially Equivalent	Howmedica Corp.