KRO · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Orthopedic · 21 CFR 888.3510 · Class 2
Overview
| Product Code | KRO |
|---|---|
| Device Name | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
| Regulation | 21 CFR 888.3510 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).
Classification Rationale
Class II.
Cleared Devices (86)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Dec 15, 2025 | SESE |
| K252303 | Stem Extension Line (USTAR II System) | United Orthopedic Corporation | Aug 22, 2025 | SESE |
| K251665 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Jul 25, 2025 | SESE |
| K242871 | ATTUNE Revision Hinge Knee | Depuy Ireland UC | Nov 21, 2024 | SESE |
| 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 | Microport Orthopedics, Inc. | Apr 1, 2024 | SESE |
| K233980 | ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System | Depuy Ireland UC | Mar 21, 2024 | SESE |
| K230563 | EVOLUTION® Hinge Knee System | Microport Orthopedics, Inc. | Sep 27, 2023 | SESE |
| K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® | Stryker | May 19, 2023 | SESE |
| K223069 | Modular Rotating Hinge Knee Systems and Compatible Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Apr 21, 2023 | SESE |
| K223528 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Jan 20, 2023 | SESE |
| K220628 | LINK Endo-Model EVO Knee System | Waldemar Link GmbH & Co. KG | May 3, 2022 | SESE |
| K211677 | ELEOS Limb Salvage System | Onkos Surgical | Jul 28, 2021 | SESE |
| K211768 | LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE | Waldemar Link GmbH & Co. KG | Jun 30, 2021 | SESE |
| K210010 | GMK Revision & Hinge Extension - TiNbN Coating | Medacta International S.A. | Mar 2, 2021 | SESE |
| K192798 | Zimmer Segmental System | Zimmer, Inc. | Dec 10, 2020 | SESE |
| K190181 | Instruments for LINK MEGASYSTEM-C Family | LinkBio Corp. | Oct 25, 2019 | SESE |
| K191779 | Attune Revision LPS Inserts | Depuy(Ireland) | Oct 8, 2019 | SESE |
| K190100 | USTAR II System | United Orthopedic Corporation | Sep 23, 2019 | SESE |
| K172347 | GMK Hinge, GMK Revision | Medacta International S.A. | Nov 1, 2017 | SESE |
| K163311 | GMK Revision Femoral Distal Augmentation | Medacta International S.A. | Dec 21, 2016 | SESE |
| K161520 | ELEOS Limb Salvage System | Onkos Surgical, Inc. | Oct 28, 2016 | SESE |
| K152431 | LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating | Waldemar Link GmbH & Co. KG | May 9, 2016 | SESE |
| K151008 | LINK® MEGASYSTEM-C® | Waldemar Link GmbH & Co. KG | Aug 26, 2015 | SESE |
| K151118 | Smith and Nephew Legion Hinge Knee System | Smith & Nephew | Jul 28, 2015 | SESE |
| K140900 | PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT | Stanmore Worldwide Implants , Ltd. | Feb 12, 2015 | SESE |
| K150028 | Zimmer Segmental System XT Components | Zimmer, Inc. | Feb 6, 2015 | SESE |
| K143179 | The LINK® Endo-Model® Knee System | Waldemar Link GmbH & Co. KG | Jan 30, 2015 | SESE |
| K140898 | PATIENT SPECIFIC DISTAL FEMORAL | Stanmore Implants Worldwide , Ltd. | Jan 20, 2015 | SESE |
| K140509 | BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE | Biomet Manufacturing, LLC | May 28, 2014 | SESE |
| K133152 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | Stanmore Implants Worldwide , Ltd. | Jan 22, 2014 | SESE |
| K131393 | MAK OSS FEMORAL KNEE COMPONENTS | Biomet Orthopedics Corp. | Oct 24, 2013 | SESE |
| K130299 | GMK HINGE | Medacta International | Aug 15, 2013 | SESE |
| K122015 | DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE | Howmedica Osteonics Corp. | Feb 22, 2013 | SESE |
| K121029 | METS MODULAR DISTAL FEMUR | Stanmore Implants Worldwide , Ltd. | Sep 19, 2012 | SESE |
| K120992 | METS SMILES TOTAL KNEE REPLACEMENT | Stanmore Implants Worldwide , Ltd. | Sep 5, 2012 | SESE |
| K110940 | ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN | Zimmer, Inc. | Jul 1, 2011 | SESE |
| K092138 | JTS EXTENDEABLE IMPLANT | Stanmore Implants Worldwide , Ltd. | Mar 22, 2011 | SESE |
| K101815 | ENDURO KNEE SYSTEM | Aesculap Implant Systems | Dec 20, 2010 | SESE |
| K091453 | LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331 | DePuy Orthopaedics, Inc. | Aug 12, 2009 | SESE |
| K083779 | MAK OSS KNEE FEMORAL COMPONENTS | Biomet Manufacturing Corp | Apr 3, 2009 | SESE |
| K083827 | ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES | Biomet Manufacturing Corp | Feb 13, 2009 | SESE |
| K081111 | LEGION HINGE KNEE SYSTEM | Smith & Nephew, Inc. | Jul 23, 2008 | SESE |
| K080330 | SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER | Biomet, Inc. | Jun 11, 2008 | SESE |
| K072367 | REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR | Wrightmedicaltechnologyinc | Jan 9, 2008 | SESE |
| K070978 | ZIMMER SEGMENTAL SYSTEM | Zimmer, Inc. | Jul 3, 2007 | SESE |
| K062301 | DEPUY LPS PROXIMAL TIBIAL COMPONENT | DePuy Orthopaedics, Inc. | Oct 13, 2006 | SESE |
| K060360 | HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAPTERS | Howmedica Osteonics Corp. | Mar 15, 2006 | SESE |
| K060131 | OSS-BODIES PROXIMAL TIBIAL SLEEVE | Biomet Manufacturing Corp | Feb 15, 2006 | SESE |
| K052685 | ORTHOPEDIC SALVAGE SYSTEM- OSS | Biomet, Inc. | Oct 27, 2005 | SESE |
| K051479 | RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS | Biomet Manufacturing, Inc. | Aug 10, 2005 | SESE |
| K051570 | AVL HINGE KNEE SYSTEM | Biomet, Inc. | Aug 5, 2005 | SESE |
| K041352 | COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM | Biomet, Inc. | Jul 30, 2004 | SESE |
| K040749 | MODULAR REPLACEMENT SYSTEM CEMENTED STEMS | Howmedica Osteonics Corp. | Jun 17, 2004 | SESE |
| K031804 | COMPRESS DISTAL FEMORAL REPLACEMENT | Biomet, Inc. | Dec 18, 2003 | SESE |
| K031480 | GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT | Howmedica Osteonics Corp. | Jul 31, 2003 | SESE |
| K023667 | RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE | Plus Orthopedics | Dec 24, 2002 | SESE |
| K023087 | GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS) | Howmedica Osteonics Corp. | Dec 16, 2002 | SESE |
| K021489 | REPIPHYSIS LIMB SALVAGE SYSTEM | Wrightmedicaltechnologyinc | Dec 4, 2002 | SESE |
| K021714 | RT-PLUS PE INSERT CLAMP | Plus Orthopedics | Jun 21, 2002 | SESE |
| K021260 | REDUCED SIZE ONCOLOGY SALVAGE SYSTEM | Biomet, Inc. | Jun 5, 2002 | SESE |
| K020381 | EXPANDABLE KNEE | Biomet Orthopedics, Inc. | May 6, 2002 | SESE |
| K013385 | NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE | Zimmer, Inc. | Jan 9, 2002 | SESE |
| K013340 | RT-PLUS KNEE ADDITIONAL COMPONENTS | Plus Orthopedics | Dec 20, 2001 | SESE |
| K013035 | GUARDIAN LIMB SALVAGE SYSTEM | Wrightmedicaltechnologyinc | Dec 7, 2001 | SESE |
| K013031 | MOST OPTIONS SYSTEM | Sulzer Orthopedics, Inc. | Dec 7, 2001 | SESE |
| K011810 | ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING | Depuy, Inc. | Sep 7, 2001 | SESE |
| K003504 | RT-PLUS MODULAR CEMENTED KNEE COMPONENTS | Plus Orthopedics | May 11, 2001 | SESE |
| K010774 | AVL HINGE KNEE SYSTEM | Biomet, Inc. | Apr 13, 2001 | SESE |
| K002552 | HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE | Howmedica Osteonics Corp. | Nov 13, 2000 | SESE |
| K001957 | MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT | Howmedica Osteonics Corp. | Jul 25, 2000 | SESE |
| K001548 | MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS | Howmedica Osteonics Corp. | Jun 7, 2000 | SESE |
| K994207 | HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE | Howmedica Osteonics Corp. | Mar 13, 2000 | SESE |
| K982160 | HINGED KNEE | Encore Orthopedics, Inc. | Mar 17, 1999 | SESE |
| K972401 | HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS | Howmedica Corp. | Jul 13, 1998 | SESE |
| K945028 | FINN KNEE SYSTEM | Biomet, Inc. | Feb 14, 1996 | SN |
| K910877 | FINN KNEE PROSTHESIS | Biomet, Inc. | Jul 26, 1991 | SESE |
| K910596 | DCW MODULAR DISTAL FEMORAL SYSTEM | Dow Corning Wright | May 29, 1991 | SESE |
| K896048 | S-ROM/NOILES MARK 3 | Joint Medical Products Corp. | Mar 14, 1990 | SESE |
| K823420 | KINEMATIC II KNEE SYSTEM | Howmedica Corp. | Feb 7, 1983 | SESE |
| K823115 | NATURALYTE BICARBONATE DIALYSATE 4400 | Erika, Inc. | Dec 3, 1982 | SESE |
| K821476 | BARD ENDO LINK INTRACONDYLAR ROTATING | C.R. Bard, Inc. | Jun 23, 1982 | SESE |
| K821340 | VARIAXIAL CONSTRAINED TOTAL KNEE PROSTH. | Intermedics Orthopedics | May 27, 1982 | SESE |
| K820995 | MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS | Ludek Optics, Inc. | May 25, 1982 | SESE |
| K811105 | SEMI-CONSTRAINT KEE JOINT HINGE PROSTH | Allo Pro Corp. | Jul 27, 1981 | SESE |
| K810520 | INSALL/BURSTEIN CONSTRAINED TOTAL CONDYL | Zimmer, Inc. | Mar 26, 1981 | SESE |
| K781971 | KNEE SYSTEM, QUADRAXIAL CONSTRAINED | Hexcel Medical | Apr 4, 1979 | SESE |
Top Applicants
- Howmedica Osteonics Corp. — 9 clearances
- Biomet, Inc. — 9 clearances
- Zimmer, Inc. — 6 clearances
- Waldemar Link GmbH & Co. KG — 5 clearances
- Stanmore Implants Worldwide , Ltd. — 5 clearances
