Product Code: KRO FDA class 2 21 CFR 888.3510

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Orthopedic

This device is a constrained cemented femorotibial knee prosthesis made from metal and polymer, used in total knee replacement surgery for patients who require a higher degree of mechanical constraint due to ligament insufficiency or severe joint deformity. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KRO, regulated under 21 CFR 888.3510 within the Orthopedic specialty. This device is designated as an implant.

View on FDA

510(k)s

FEI Numbers

137

Registration Numbers

137

Unique Applicants

Years Active

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Basic Information

Product Code: KRO
Device Class: FDA class 2
Regulation Number: 888.3510
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 86 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252898	Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper	Dec 15, 2025	Substantially Equivalent	Howmedica Osteonics Corp., Dba Stryker Orthopaedics
K252303	Stem Extension Line (USTAR II System)	Aug 22, 2025	Substantially Equivalent	United Orthopedic Corporation
K251665	Triathlon® Hinge Knee System	Jul 25, 2025	Substantially Equivalent	Howmedica Osteonics Corp., Dba Stryker Orthopaedics
K242871	ATTUNE Revision Hinge Knee	Nov 21, 2024	Substantially Equivalent	Depuy Ireland UC
K240043	EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse	Apr 01, 2024	Substantially Equivalent	Microport Orthopedics, Inc.
K233980	ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System	Mar 21, 2024	Substantially Equivalent	Depuy Ireland UC
K230563	EVOLUTION® Hinge Knee System	Sep 27, 2023	Substantially Equivalent	Microport Orthopedics, Inc.
K230416	Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®	May 19, 2023	Substantially Equivalent	Stryker
K223069	Modular Rotating Hinge Knee Systems and Compatible Components	Apr 21, 2023	Substantially Equivalent	Howmedica Osteonics Corp., Dba Stryker Orthopaedics
K223528	Triathlon® Hinge Knee System	Jan 20, 2023	Substantially Equivalent	Howmedica Osteonics Corp., Dba Stryker Orthopaedics
K220628	LINK Endo-Model EVO Knee System	May 03, 2022	Substantially Equivalent	Waldemar Link GmbH & Co. KG
K211677	ELEOS Limb Salvage System	Jul 28, 2021	Substantially Equivalent	Onkos Surgical
K211768	LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE	Jun 30, 2021	Substantially Equivalent	Waldemar Link GmbH & Co. KG
K210010	GMK Revision & Hinge Extension - TiNbN Coating	Mar 02, 2021	Substantially Equivalent	Medacta International S.A.
K192798	Zimmer Segmental System	Dec 10, 2020	Substantially Equivalent	Zimmer, Inc.
K190181	Instruments for LINK MEGASYSTEM-C Family	Oct 25, 2019	Substantially Equivalent	LinkBio Corp.
K191779	Attune Revision LPS Inserts	Oct 08, 2019	Substantially Equivalent	Depuy(Ireland)
K190100	USTAR II System	Sep 23, 2019	Substantially Equivalent	United Orthopedic Corporation
K172347	GMK Hinge, GMK Revision	Nov 01, 2017	Substantially Equivalent	Medacta International S.A.
K163311	GMK Revision Femoral Distal Augmentation	Dec 21, 2016	Substantially Equivalent	Medacta International S.A.
K161520	ELEOS Limb Salvage System	Oct 28, 2016	Substantially Equivalent	Onkos Surgical, Inc.
K152431	LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating	May 09, 2016	Substantially Equivalent	Waldemar Link GmbH & Co. KG
K151008	LINK® MEGASYSTEM-C®	Aug 26, 2015	Substantially Equivalent	Waldemar Link GmbH & Co. KG
K151118	Smith and Nephew Legion Hinge Knee System	Jul 28, 2015	Substantially Equivalent	Smith & Nephew
K140900	PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT	Feb 12, 2015	Substantially Equivalent	Stanmore Worldwide Implants , Ltd.
K150028	Zimmer Segmental System XT Components	Feb 06, 2015	Substantially Equivalent	Zimmer, Inc.
K143179	The LINK® Endo-Model® Knee System	Jan 30, 2015	Substantially Equivalent	Waldemar Link GmbH & Co. KG
K140898	PATIENT SPECIFIC DISTAL FEMORAL	Jan 20, 2015	Substantially Equivalent	Stanmore Implants Worldwide , Ltd.
K140509	BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE	May 28, 2014	Substantially Equivalent	Biomet Manufacturing, LLC
K133152	JTS EXTENDIBLE DISTAL FEMORAL IMPLANT	Jan 22, 2014	Substantially Equivalent	Stanmore Implants Worldwide , Ltd.
K131393	MAK OSS FEMORAL KNEE COMPONENTS	Oct 24, 2013	Substantially Equivalent	Biomet Orthopedics Corp.
K130299	GMK HINGE	Aug 15, 2013	Substantially Equivalent	Medacta International
K122015	DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE	Feb 22, 2013	Substantially Equivalent	Howmedica Osteonics Corp.
K121029	METS MODULAR DISTAL FEMUR	Sep 19, 2012	Substantially Equivalent	Stanmore Implants Worldwide , Ltd.
K120992	METS SMILES TOTAL KNEE REPLACEMENT	Sep 05, 2012	Substantially Equivalent	Stanmore Implants Worldwide , Ltd.
K110940	ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN	Jul 01, 2011	Substantially Equivalent	Zimmer, Inc.
K092138	JTS EXTENDEABLE IMPLANT	Mar 22, 2011	Substantially Equivalent	Stanmore Implants Worldwide , Ltd.
K101815	ENDURO KNEE SYSTEM	Dec 20, 2010	Substantially Equivalent	Aesculap Implant Systems
K091453	LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331	Aug 12, 2009	Substantially Equivalent	DePuy Orthopaedics, Inc.
K083779	MAK OSS KNEE FEMORAL COMPONENTS	Apr 03, 2009	Substantially Equivalent	Biomet Manufacturing Corp
K083827	ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES	Feb 13, 2009	Substantially Equivalent	Biomet Manufacturing Corp
K081111	LEGION HINGE KNEE SYSTEM	Jul 23, 2008	Substantially Equivalent	Smith & Nephew, Inc.
K080330	SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER	Jun 11, 2008	Substantially Equivalent	Biomet, Inc.
K072367	REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR	Jan 09, 2008	Substantially Equivalent	Wrightmedicaltechnologyinc
K070978	ZIMMER SEGMENTAL SYSTEM	Jul 03, 2007	Substantially Equivalent	Zimmer, Inc.
K062301	DEPUY LPS PROXIMAL TIBIAL COMPONENT	Oct 13, 2006	Substantially Equivalent	DePuy Orthopaedics, Inc.
K060360	HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAPTERS	Mar 15, 2006	Substantially Equivalent	Howmedica Osteonics Corp.
K060131	OSS-BODIES PROXIMAL TIBIAL SLEEVE	Feb 15, 2006	Substantially Equivalent	Biomet Manufacturing Corp
K052685	ORTHOPEDIC SALVAGE SYSTEM- OSS	Oct 27, 2005	Substantially Equivalent	Biomet, Inc.
K051479	RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS	Aug 10, 2005	Substantially Equivalent	Biomet Manufacturing, Inc.
K051570	AVL HINGE KNEE SYSTEM	Aug 05, 2005	Substantially Equivalent	Biomet, Inc.
K041352	COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM	Jul 30, 2004	Substantially Equivalent	Biomet, Inc.
K040749	MODULAR REPLACEMENT SYSTEM CEMENTED STEMS	Jun 17, 2004	Substantially Equivalent	Howmedica Osteonics Corp.
K031804	COMPRESS DISTAL FEMORAL REPLACEMENT	Dec 18, 2003	Substantially Equivalent	Biomet, Inc.
K031480	GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT	Jul 31, 2003	Substantially Equivalent	Howmedica Osteonics Corp.
K023667	RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE	Dec 24, 2002	Substantially Equivalent	Plus Orthopedics
K023087	GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)	Dec 16, 2002	Substantially Equivalent	Howmedica Osteonics Corp.
K021489	REPIPHYSIS LIMB SALVAGE SYSTEM	Dec 04, 2002	Substantially Equivalent	Wrightmedicaltechnologyinc
K021714	RT-PLUS PE INSERT CLAMP	Jun 21, 2002	Substantially Equivalent	Plus Orthopedics
K021260	REDUCED SIZE ONCOLOGY SALVAGE SYSTEM	Jun 05, 2002	Substantially Equivalent	Biomet, Inc.
K020381	EXPANDABLE KNEE	May 06, 2002	Substantially Equivalent	Biomet Orthopedics, Inc.
K013385	NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE	Jan 09, 2002	Substantially Equivalent	Zimmer, Inc.
K013340	RT-PLUS KNEE ADDITIONAL COMPONENTS	Dec 20, 2001	Substantially Equivalent	Plus Orthopedics
K013035	GUARDIAN LIMB SALVAGE SYSTEM	Dec 07, 2001	Substantially Equivalent	Wrightmedicaltechnologyinc
K013031	MOST OPTIONS SYSTEM	Dec 07, 2001	Substantially Equivalent	Sulzer Orthopedics, Inc.
K011810	ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING	Sep 07, 2001	Substantially Equivalent	Depuy, Inc.
K003504	RT-PLUS MODULAR CEMENTED KNEE COMPONENTS	May 11, 2001	Substantially Equivalent	Plus Orthopedics
K010774	AVL HINGE KNEE SYSTEM	Apr 13, 2001	Substantially Equivalent	Biomet, Inc.
K002552	HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE	Nov 13, 2000	Substantially Equivalent	Howmedica Osteonics Corp.
K001957	MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT	Jul 25, 2000	Substantially Equivalent	Howmedica Osteonics Corp.
K001548	MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS	Jun 07, 2000	Substantially Equivalent	Howmedica Osteonics Corp.
K994207	HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE	Mar 13, 2000	Substantially Equivalent	Howmedica Osteonics Corp.
K982160	HINGED KNEE	Mar 17, 1999	Substantially Equivalent	Encore Orthopedics, Inc.
K972401	HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS	Jul 13, 1998	Substantially Equivalent	Howmedica Corp.
K945028	FINN KNEE SYSTEM	Feb 14, 1996	Substantially Equivalent for Some Indications	Biomet, Inc.
K910877	FINN KNEE PROSTHESIS	Jul 26, 1991	Substantially Equivalent	Biomet, Inc.
K910596	DCW MODULAR DISTAL FEMORAL SYSTEM	May 29, 1991	Substantially Equivalent	Dow Corning Wright
K896048	S-ROM/NOILES MARK 3	Mar 14, 1990	Substantially Equivalent	Joint Medical Products Corp.
K823420	KINEMATIC II KNEE SYSTEM	Feb 07, 1983	Substantially Equivalent	Howmedica Corp.
K823115	NATURALYTE BICARBONATE DIALYSATE 4400	Dec 03, 1982	Substantially Equivalent	Erika, Inc.
K821476	BARD ENDO LINK INTRACONDYLAR ROTATING	Jun 23, 1982	Substantially Equivalent	C.R. Bard, Inc.
K821340	VARIAXIAL CONSTRAINED TOTAL KNEE PROSTH.	May 27, 1982	Substantially Equivalent	Intermedics Orthopedics
K820995	MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS	May 25, 1982	Substantially Equivalent	Ludek Optics, Inc.
K811105	SEMI-CONSTRAINT KEE JOINT HINGE PROSTH	Jul 27, 1981	Substantially Equivalent	Allo Pro Corp.
K810520	INSALL/BURSTEIN CONSTRAINED TOTAL CONDYL	Mar 26, 1981	Substantially Equivalent	Zimmer, Inc.
K781971	KNEE SYSTEM, QUADRAXIAL CONSTRAINED	Apr 04, 1979	Substantially Equivalent	Hexcel Medical