FDA Product Code
FDA Product Code KRO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3510
510(k) Clearances — 87 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System | Howmedica Osteonics Corp. dba Stryker Orthopaedics | 2026-08-06 | Traditional | PDF ↗ |
| 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 | 2025-12-15 | Traditional | PDF ↗ |
| K252303 | Stem Extension Line (USTAR II System) | United Orthopedic Corporation | 2025-08-22 | Special | PDF ↗ |
| K251665 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-07-25 | Traditional | PDF ↗ |
| K242871 | ATTUNE Revision Hinge Knee | Depuy Ireland UC | 2024-11-21 | Traditional | PDF ↗ |
| 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. | 2024-04-01 | Traditional | PDF ↗ |
| K233980 | ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System | Depuy Ireland UC | 2024-03-21 | Traditional | PDF ↗ |
| K230563 | EVOLUTION® Hinge Knee System | Microport Orthopedics, Inc. | 2023-09-27 | Traditional | PDF ↗ |
| K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® | Stryker | 2023-05-19 | Traditional | PDF ↗ |
| K223069 | Modular Rotating Hinge Knee Systems and Compatible Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-04-21 | Traditional | PDF ↗ |
| K223528 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-01-20 | Traditional | PDF ↗ |
| K220628 | LINK Endo-Model EVO Knee System | Waldemar Link GmbH & Co. KG | 2022-05-03 | Traditional | PDF ↗ |
| K211677 | ELEOS Limb Salvage System | Onkos Surgical | 2021-07-28 | Traditional | PDF ↗ |
| K211768 | LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE | Waldemar Link GmbH & Co. KG | 2021-06-30 | Special | PDF ↗ |
| K210010 | GMK Revision & Hinge Extension - TiNbN Coating | Medacta International S.A. | 2021-03-02 | Traditional | PDF ↗ |
| K192798 | Zimmer Segmental System | Zimmer, Inc. | 2020-12-10 | Traditional | PDF ↗ |
| K190181 | Instruments for LINK MEGASYSTEM-C Family | LinkBio Corp. | 2019-10-25 | Traditional | PDF ↗ |
| K191779 | Attune Revision LPS Inserts | Depuy(Ireland) | 2019-10-08 | Traditional | PDF ↗ |
| K190100 | USTAR II System | United Orthopedic Corporation | 2019-09-23 | Traditional | PDF ↗ |
| K172347 | GMK Hinge, GMK Revision | Medacta International S.A. | 2017-11-01 | Traditional | PDF ↗ |
| K163311 | GMK Revision Femoral Distal Augmentation | Medacta International S.A. | 2016-12-21 | Special | PDF ↗ |
| K161520 | ELEOS Limb Salvage System | Onkos Surgical, Inc. | 2016-10-28 | Traditional | PDF ↗ |
| K152431 | LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating | Waldemar Link GmbH & Co. KG | 2016-05-09 | Traditional | PDF ↗ |
| K151008 | LINK® MEGASYSTEM-C® | Waldemar Link GmbH & Co. KG | 2015-08-26 | Traditional | PDF ↗ |
| K151118 | Smith and Nephew Legion Hinge Knee System | Smith & Nephew | 2015-07-28 | Traditional | PDF ↗ |
| K140900 | PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT | Stanmore Worldwide Implants , Ltd. | 2015-02-12 | Special | PDF ↗ |
| K150028 | Zimmer Segmental System XT Components | Zimmer, Inc. | 2015-02-06 | Special | PDF ↗ |
| K143179 | The LINK® Endo-Model® Knee System | Waldemar Link GmbH & Co. KG | 2015-01-30 | Traditional | PDF ↗ |
| K140898 | PATIENT SPECIFIC DISTAL FEMORAL | Stanmore Implants Worldwide , Ltd. | 2015-01-20 | Special | PDF ↗ |
| K140509 | BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE | Biomet Manufacturing, LLC | 2014-05-28 | Traditional | PDF ↗ |
| K133152 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | Stanmore Implants Worldwide , Ltd. | 2014-01-22 | Special | PDF ↗ |
| K131393 | MAK OSS FEMORAL KNEE COMPONENTS | Biomet Orthopedics Corp. | 2013-10-24 | Traditional | PDF ↗ |
| K130299 | GMK HINGE | Medacta International | 2013-08-15 | Traditional | PDF ↗ |
| K122015 | DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE | Howmedica Osteonics Corp. | 2013-02-22 | Traditional | PDF ↗ |
| K121029 | METS MODULAR DISTAL FEMUR | Stanmore Implants Worldwide , Ltd. | 2012-09-19 | Traditional | PDF ↗ |
| K120992 | METS SMILES TOTAL KNEE REPLACEMENT | Stanmore Implants Worldwide , Ltd. | 2012-09-05 | Traditional | PDF ↗ |
| K110940 | ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN | Zimmer, Inc. | 2011-07-01 | Traditional | PDF ↗ |
| K092138 | JTS EXTENDEABLE IMPLANT | Stanmore Implants Worldwide , Ltd. | 2011-03-22 | Traditional | PDF ↗ |
| K101815 | ENDURO KNEE SYSTEM | Aesculap Implant Systems | 2010-12-20 | Traditional | PDF ↗ |
| K091453 | LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331 | DePuy Orthopaedics, Inc. | 2009-08-12 | Traditional | PDF ↗ |
| K083779 | MAK OSS KNEE FEMORAL COMPONENTS | Biomet Manufacturing Corp | 2009-04-03 | Traditional | PDF ↗ |
| K083827 | ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES | Biomet Manufacturing Corp | 2009-02-13 | Special | PDF ↗ |
| K081111 | LEGION HINGE KNEE SYSTEM | Smith & Nephew, Inc. | 2008-07-23 | Traditional | PDF ↗ |
| K080330 | SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER | Biomet, Inc. | 2008-06-11 | Traditional | PDF ↗ |
| K072367 | REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR | Wrightmedicaltechnologyinc | 2008-01-09 | Traditional | PDF ↗ |
| K070978 | ZIMMER SEGMENTAL SYSTEM | Zimmer, Inc. | 2007-07-03 | Traditional | PDF ↗ |
| K062301 | DEPUY LPS PROXIMAL TIBIAL COMPONENT | DePuy Orthopaedics, Inc. | 2006-10-13 | Special | PDF ↗ |
| K060360 | HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAPTERS | Howmedica Osteonics Corp. | 2006-03-15 | Special | PDF ↗ |
| K060131 | OSS-BODIES PROXIMAL TIBIAL SLEEVE | Biomet Manufacturing Corp | 2006-02-15 | Special | PDF ↗ |
| K052685 | ORTHOPEDIC SALVAGE SYSTEM- OSS | Biomet, Inc. | 2005-10-27 | Special | PDF ↗ |
| K051479 | RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS | Biomet Manufacturing, Inc. | 2005-08-10 | Traditional | PDF ↗ |
| K051570 | AVL HINGE KNEE SYSTEM | Biomet, Inc. | 2005-08-05 | Traditional | PDF ↗ |
| K041352 | COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM | Biomet, Inc. | 2004-07-30 | Traditional | PDF ↗ |
| K040749 | MODULAR REPLACEMENT SYSTEM CEMENTED STEMS | Howmedica Osteonics Corp. | 2004-06-17 | Traditional | PDF ↗ |
| K031804 | COMPRESS DISTAL FEMORAL REPLACEMENT | Biomet, Inc. | 2003-12-18 | Traditional | PDF ↗ |
| K031480 | GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT | Howmedica Osteonics Corp. | 2003-07-31 | Traditional | PDF ↗ |
| K023667 | RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE | Plus Orthopedics | 2002-12-24 | Special | PDF ↗ |
| K023087 | GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS) | Howmedica Osteonics Corp. | 2002-12-16 | Traditional | PDF ↗ |
| K021489 | REPIPHYSIS LIMB SALVAGE SYSTEM | Wrightmedicaltechnologyinc | 2002-12-04 | Traditional | PDF ↗ |
| K021714 | RT-PLUS PE INSERT CLAMP | Plus Orthopedics | 2002-06-21 | Special | PDF ↗ |
| K021260 | REDUCED SIZE ONCOLOGY SALVAGE SYSTEM | Biomet, Inc. | 2002-06-05 | Traditional | PDF ↗ |
| K020381 | EXPANDABLE KNEE | Biomet Orthopedics, Inc. | 2002-05-06 | Traditional | PDF ↗ |
| K013385 | NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE | Zimmer, Inc. | 2002-01-09 | Traditional | PDF ↗ |
| K013340 | RT-PLUS KNEE ADDITIONAL COMPONENTS | Plus Orthopedics | 2001-12-20 | Special | PDF ↗ |
| K013035 | GUARDIAN LIMB SALVAGE SYSTEM | Wrightmedicaltechnologyinc | 2001-12-07 | Traditional | PDF ↗ |
| K013031 | MOST OPTIONS SYSTEM | Sulzer Orthopedics, Inc. | 2001-12-07 | Traditional | PDF ↗ |
| K011810 | ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING | Depuy, Inc. | 2001-09-07 | Traditional | PDF ↗ |
| K003504 | RT-PLUS MODULAR CEMENTED KNEE COMPONENTS | Plus Orthopedics | 2001-05-11 | Traditional | PDF ↗ |
| K010774 | AVL HINGE KNEE SYSTEM | Biomet, Inc. | 2001-04-13 | Special | PDF ↗ |
| K002552 | HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE | Howmedica Osteonics Corp. | 2000-11-13 | Traditional | PDF ↗ |
| K001957 | MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT | Howmedica Osteonics Corp. | 2000-07-25 | Special | PDF ↗ |
| K001548 | MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS | Howmedica Osteonics Corp. | 2000-06-07 | Special | PDF ↗ |
| K994207 | HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE | Howmedica Osteonics Corp. | 2000-03-13 | Traditional | PDF ↗ |
| K982160 | HINGED KNEE | Encore Orthopedics, Inc. | 1999-03-17 | Traditional | PDF ↗ |
| K972401 | HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS | Howmedica Corp. | 1998-07-13 | Traditional | PDF ↗ |
| K945028 | FINN KNEE SYSTEM | Biomet, Inc. | 1996-02-14 | Traditional | PDF ↗ |
| K910877 | FINN KNEE PROSTHESIS | Biomet, Inc. | 1991-07-26 | Traditional | PDF ↗ |
| K910596 | DCW MODULAR DISTAL FEMORAL SYSTEM | Dow Corning Wright | 1991-05-29 | Traditional | PDF ↗ |
| K896048 | S-ROM/NOILES MARK 3 | Joint Medical Products Corp. | 1990-03-14 | Traditional | PDF ↗ |
| K823420 | KINEMATIC II KNEE SYSTEM | Howmedica Corp. | 1983-02-07 | Traditional | PDF ↗ |
| K823115 | NATURALYTE BICARBONATE DIALYSATE 4400 | Erika, Inc. | 1982-12-03 | Traditional | PDF ↗ |
| K821476 | BARD ENDO LINK INTRACONDYLAR ROTATING | C.R. Bard, Inc. | 1982-06-23 | Traditional | PDF ↗ |
| K821340 | VARIAXIAL CONSTRAINED TOTAL KNEE PROSTH. | Intermedics Orthopedics | 1982-05-27 | Traditional | PDF ↗ |
| K820995 | MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS | Ludek Optics, Inc. | 1982-05-25 | Traditional | PDF ↗ |
| K811105 | SEMI-CONSTRAINT KEE JOINT HINGE PROSTH | Allo Pro Corp. | 1981-07-27 | Traditional | PDF ↗ |
| K810520 | INSALL/BURSTEIN CONSTRAINED TOTAL CONDYL | Zimmer, Inc. | 1981-03-26 | Traditional | PDF ↗ |
| K781971 | KNEE SYSTEM, QUADRAXIAL CONSTRAINED | Hexcel Medical | 1979-04-04 | Traditional | PDF ↗ |
Product code KRO · Class II · Orthopedic. Data: openFDA.