FDA 510(k) Applications for Medical Device Product Code "KRO"
(Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K101815 | AESCULAP IMPLANT SYSTEMS | ENDURO KNEE SYSTEM | 12/20/2010 |
| K083779 | BIOMET MANUFACTURING CORP. | MAK OSS KNEE FEMORAL COMPONENTS | 04/03/2009 |
| K083827 | BIOMET MANUFACTURING CORP. | ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES | 02/13/2009 |
| K060131 | BIOMET MANUFACTURING CORP. | OSS-BODIES PROXIMAL TIBIAL SLEEVE | 02/15/2006 |
| K140509 | BIOMET MANUFACTURING LLC | BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE | 05/28/2014 |
| K051479 | BIOMET MANUFACTURING, INC. | RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS | 08/10/2005 |
| K131393 | BIOMET ORTHOPEDICS CORP. | MAK OSS FEMORAL KNEE COMPONENTS | 10/24/2013 |
| K020381 | BIOMET ORTHOPEDICS, INC. | EXPANDABLE KNEE | 05/06/2002 |
| K010774 | BIOMET, INC. | AVL HINGE KNEE SYSTEM | 04/13/2001 |
| K051570 | BIOMET, INC. | AVL HINGE KNEE SYSTEM | 08/05/2005 |
| K031804 | BIOMET, INC. | COMPRESS DISTAL FEMORAL REPLACEMENT | 12/18/2003 |
| K041352 | BIOMET, INC. | COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM | 07/30/2004 |
| K945028 | BIOMET, INC. | FINN KNEE SYSTEM | 02/14/1996 |
| K052685 | BIOMET, INC. | ORTHOPEDIC SALVAGE SYSTEM- OSS | 10/27/2005 |
| K021260 | BIOMET, INC. | REDUCED SIZE ONCOLOGY SALVAGE SYSTEM | 06/05/2002 |
| K080330 | BIOMET, INC. | SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER | 06/11/2008 |
| K191779 | Depuy (Ireland) | Attune Revision LPS Inserts | 10/08/2019 |
| K062301 | DEPUY ORTHOPAEDICS, INC. | DEPUY LPS PROXIMAL TIBIAL COMPONENT | 10/13/2006 |
| K091453 | DEPUY ORTHOPAEDICS, INC. | LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331 | 08/12/2009 |
| K011810 | DEPUY, INC. | ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING | 09/07/2001 |
| K982160 | ENCORE ORTHOPEDICS, INC. | HINGED KNEE | 03/17/1999 |
| K972401 | HOWMEDICA CORP. | HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS | 07/13/1998 |
| K060360 | HOWMEDICA OSTEONICS CORP | HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAPTERS | 03/15/2006 |
| K040749 | HOWMEDICA OSTEONICS CORP | MODULAR REPLACEMENT SYSTEM CEMENTED STEMS | 06/17/2004 |
| K122015 | HOWMEDICA OSTEONICS CORP. | DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE | 02/22/2013 |
| K023087 | HOWMEDICA OSTEONICS CORP. | GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS) | 12/16/2002 |
| K031480 | HOWMEDICA OSTEONICS CORP. | GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT | 07/31/2003 |
| K002552 | HOWMEDICA OSTEONICS CORP. | HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE | 11/13/2000 |
| K994207 | HOWMEDICA OSTEONICS CORP. | HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE | 03/13/2000 |
| K001548 | HOWMEDICA OSTEONICS CORP. | MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS | 06/07/2000 |
| K001957 | HOWMEDICA OSTEONICS CORP. | MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT | 07/25/2000 |
| K223069 | Howmedica Osteonics Corp. dba Stryker Orthopaedics | Modular Rotating Hinge Knee Systems and Compatible Components | 04/21/2023 |
| K223528 | Howmedica Osteonics Corp. dba Stryker Orthopaedics | Triathlon« Hinge Knee System | 01/20/2023 |
| K190181 | Link Bio Corp. | Instruments for LINK MEGASYSTEM-C Family | 10/25/2019 |
| K130299 | MEDACTA INTERNATIONAL | GMK HINGE | 08/15/2013 |
| K172347 | Medacta International SA | GMK Hinge, GMK Revision | 11/01/2017 |
| K210010 | Medacta International SA | GMK Revision & Hinge Extension - TiNbN Coating | 03/02/2021 |
| K163311 | Medacta International SA | GMK Revision Femoral Distal Augmentation | 12/21/2016 |
| K230563 | MicroPort Orthopedics Inc. | EVOLUTION« Hinge Knee System | 09/27/2023 |
| K211677 | Onkos Surgical | ELEOS Limb Salvage System | 07/28/2021 |
| K161520 | Onkos Surgical, Inc. | ELEOS Limb Salvage System | 10/28/2016 |
| K013340 | PLUS ORTHOPEDICS | RT-PLUS KNEE ADDITIONAL COMPONENTS | 12/20/2001 |
| K003504 | PLUS ORTHOPEDICS | RT-PLUS MODULAR CEMENTED KNEE COMPONENTS | 05/11/2001 |
| K021714 | PLUS ORTHOPEDICS | RT-PLUS PE INSERT CLAMP | 06/21/2002 |
| K023667 | PLUS ORTHOPEDICS | RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE | 12/24/2002 |
| K151118 | SMITH & NEPHEW | Smith and Nephew Legion Hinge Knee System | 07/28/2015 |
| K081111 | SMITH & NEPHEW, INC. | LEGION HINGE KNEE SYSTEM | 07/23/2008 |
| K121029 | STANMORE IMPLANTS WORLDWIDE LTD | METS MODULAR DISTAL FEMUR | 09/19/2012 |
| K120992 | STANMORE IMPLANTS WORLDWIDE LTD | METS SMILES TOTAL KNEE REPLACEMENT | 09/05/2012 |
| K092138 | STANMORE IMPLANTS WORLDWIDE LTD. | JTS EXTENDEABLE IMPLANT | 03/22/2011 |
| K133152 | STANMORE IMPLANTS WORLDWIDE LTD. | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | 01/22/2014 |
| K140898 | STANMORE IMPLANTS WORLDWIDE LTD. | PATIENT SPECIFIC DISTAL FEMORAL | 01/20/2015 |
| K140900 | Stanmore Worldwide Implants Ltd. | PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT | 02/12/2015 |
| K230416 | Stryker | Triathlon« Hinge Knee System; Triathlon« Revision Insert X3« | 05/19/2023 |
| K013031 | SULZER ORTHOPEDICS, INC. | MOST OPTIONS SYSTEM | 12/07/2001 |
| K190100 | United Orthopedic Corporation | USTAR II System | 09/23/2019 |
| K220628 | Waldemar Link GmbH & Co. KG | LINK Endo-Model EVO Knee System | 05/03/2022 |
| K152431 | WALDEMAR LINK GMBH & CO. KG | LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating | 05/09/2016 |
| K211768 | Waldemar Link GmbH & Co. KG | LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE | 06/30/2021 |
| K151008 | Waldemar Link GmbH & Co. KG | LINK« MEGASYSTEM-C« | 08/26/2015 |
| K143179 | Waldemar Link GmbH & Co. KG | The LINK« Endo-Model« Knee System | 01/30/2015 |
| K013035 | WRIGHT MEDICAL TECHNOLOGY, INC. | GUARDIAN LIMB SALVAGE SYSTEM | 12/07/2001 |
| K072367 | WRIGHT MEDICAL TECHNOLOGY, INC. | REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR | 01/09/2008 |
| K021489 | WRIGHT MEDICAL TECHNOLOGY, INC. | REPIPHYSIS LIMB SALVAGE SYSTEM | 12/04/2002 |
| K013385 | ZIMMER, INC. | NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE | 01/09/2002 |
| K110940 | ZIMMER, INC. | ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN | 07/01/2011 |
| K192798 | Zimmer, Inc. | Zimmer Segmental System | 12/10/2020 |
| K070978 | ZIMMER, INC. | ZIMMER SEGMENTAL SYSTEM | 07/03/2007 |
| K150028 | ZIMMER, INC. | Zimmer Segmental System XT Components | 02/06/2015 |
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