Panels › Orthopedic › Product code KRO · Class 2
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Regulation 888.3510
2510(k)s in 12 months (87 all time)
28recalls in 12 months (124 all time)
121recalls that name a 510(k)
Top companies in KRO
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 6, 2026 | K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System Howmedica Osteonics Corp. dba Stryker Orthopaedics | KRO |
| Dec 15, 2025 | K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathl Howmedica Osteonics Corp., Dba Stryker Orthopaedics | KRO |
| Aug 22, 2025 | K252303 | Stem Extension Line (USTAR II System) United Orthopedic Corporation, TW | KRO |
| Jul 25, 2025 | K251665 | Triathlon® Hinge Knee System Howmedica Osteonics Corp., Dba Stryker Orthopaedics | KRO |
| Nov 21, 2024 | K242871 | ATTUNE Revision Hinge Knee Depuy Ireland UC, IE | KRO |
| Apr 1, 2024 | K240043 | EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS Limb Salvage Sy Microport Orthopedics, Inc. | KRO |
| Mar 21, 2024 | K233980 | ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Parti Depuy Ireland UC, IE | KRO |
| Sep 27, 2023 | K230563 | EVOLUTION® Hinge Knee System Microport Orthopedics, Inc. | KRO |
| May 19, 2023 | K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® Stryker | KRO |
| Apr 21, 2023 | K223069 | Modular Rotating Hinge Knee Systems and Compatible Components Howmedica Osteonics Corp., Dba Stryker Orthopaedics | KRO |
| Jan 20, 2023 | K223528 | Triathlon® Hinge Knee System Howmedica Osteonics Corp., Dba Stryker Orthopaedics | KRO |
| May 3, 2022 | K220628 | LINK Endo-Model EVO Knee System Waldemar Link GmbH & Co. KG, DE | KRO |
| Jul 28, 2021 | K211677 | ELEOS Limb Salvage System Onkos Surgical | KRO |
| Jun 30, 2021 | K211768 | LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE Waldemar Link GmbH & Co. KG, DE | KRO |
| Mar 2, 2021 | K210010 | GMK Revision & Hinge Extension - TiNbN Coating Medacta International S.A., CH | KRO |
| Dec 10, 2020 | K192798 | Zimmer Segmental System Zimmer, Inc. | KRO |
| Oct 25, 2019 | K190181 | Instruments for LINK MEGASYSTEM-C Family LinkBio Corp. | KRO |
| Oct 8, 2019 | K191779 | Attune Revision LPS Inserts Depuy(Ireland), IE | KRO |
| Sep 23, 2019 | K190100 | USTAR II System United Orthopedic Corporation, TW | KRO |
| Nov 1, 2017 | K172347 | GMK Hinge, GMK Revision Medacta International S.A., CH | KRO |
| Dec 21, 2016 | K163311 | GMK Revision Femoral Distal Augmentation Medacta International S.A., CH | KRO |
| Oct 28, 2016 | K161520 | ELEOS Limb Salvage System Onkos Surgical, Inc. | KRO |
| May 9, 2016 | K152431 | LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating Waldemar Link GmbH & Co. KG, DE | KRO |
| Aug 26, 2015 | K151008 | LINK® MEGASYSTEM-C® Waldemar Link GmbH & Co. KG, DE | KRO |
| Jul 28, 2015 | K151118 | Smith and Nephew Legion Hinge Knee System Smith & Nephew | KRO |
| Feb 12, 2015 | K140900 | PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT Stanmore Worldwide Implants , Ltd. | KRO |
| Feb 6, 2015 | K150028 | Zimmer Segmental System XT Components Zimmer, Inc. | KRO |
| Jan 30, 2015 | K143179 | The LINK® Endo-Model® Knee System Waldemar Link GmbH & Co. KG, DE | KRO |
| Jan 20, 2015 | K140898 | PATIENT SPECIFIC DISTAL FEMORAL Stanmore Implants Worldwide , Ltd. | KRO |
| May 28, 2014 | K140509 | BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE Biomet Manufacturing, LLC | KRO |
| Jan 22, 2014 | K133152 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT Stanmore Implants Worldwide , Ltd. | KRO |
| Oct 24, 2013 | K131393 | MAK OSS FEMORAL KNEE COMPONENTS Biomet Orthopedics Corp. | KRO |
| Aug 15, 2013 | K130299 | GMK HINGE Medacta International | KRO |
| Feb 22, 2013 | K122015 | DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE Howmedica Osteonics Corp. | KRO |
| Sep 19, 2012 | K121029 | METS MODULAR DISTAL FEMUR Stanmore Implants Worldwide , Ltd. | KRO |
| Sep 5, 2012 | K120992 | METS SMILES TOTAL KNEE REPLACEMENT Stanmore Implants Worldwide , Ltd. | KRO |
| Jul 1, 2011 | K110940 | ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN Zimmer, Inc. | KRO |
| Mar 22, 2011 | K092138 | JTS EXTENDEABLE IMPLANT Stanmore Implants Worldwide , Ltd. | KRO |
| Dec 20, 2010 | K101815 | ENDURO KNEE SYSTEM Aesculap Implant Systems | KRO |
| Aug 12, 2009 | K091453 | LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331 DePuy Orthopaedics, Inc. | KRO |
| Apr 3, 2009 | K083779 | MAK OSS KNEE FEMORAL COMPONENTS Biomet Manufacturing Corp | KRO |
| Feb 13, 2009 | K083827 | ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES Biomet Manufacturing Corp | KRO |
| Jul 23, 2008 | K081111 | LEGION HINGE KNEE SYSTEM Smith & Nephew, Inc. | KRO |
| Jun 11, 2008 | K080330 | SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER Biomet, Inc. | KRO |
| Jan 9, 2008 | K072367 | REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR Wrightmedicaltechnologyinc | KRO |
| Jul 3, 2007 | K070978 | ZIMMER SEGMENTAL SYSTEM Zimmer, Inc. | KRO |
| Oct 13, 2006 | K062301 | DEPUY LPS PROXIMAL TIBIAL COMPONENT DePuy Orthopaedics, Inc. | KRO |
| Mar 15, 2006 | K060360 | HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAPTERS Howmedica Osteonics Corp. | KRO |
| Feb 15, 2006 | K060131 | OSS-BODIES PROXIMAL TIBIAL SLEEVE Biomet Manufacturing Corp | KRO |
| Oct 27, 2005 | K052685 | ORTHOPEDIC SALVAGE SYSTEM- OSS Biomet, Inc. | KRO |
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