Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KRO — Predicate Candidate Screening
87 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
257 days90th percentile
87clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpi | Howmedica Osteonics Corp. dba Stryker Orthopaedics | 2026-08-06 | 62 | 0 |
| K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritani | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-12-15 | 95 | 0 |
| K252303 | Stem Extension Line (USTAR II System) | United Orthopedic Corporation | 2025-08-22 | 29 | 0 |
| K251665 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-07-25 | 56 | 0 |
| K242871 | ATTUNE™ Revision Hinge Knee | Depuy Ireland UC | 2024-11-21 | 59 | 11 |
| K240043 | EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;D | Microport Orthopedics, Inc. | 2024-04-01 | 87 | 0 |
| K233980 | ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS | Depuy Ireland UC | 2024-03-21 | 94 | 0 |
| K230563 | EVOLUTION® Hinge Knee System | Microport Orthopedics, Inc. | 2023-09-27 | 210 | 0 |
| K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® | Stryker | 2023-05-19 | 92 | 0 |
| K223069 | Modular Rotating Hinge Knee Systems and Compatible Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-04-21 | 203 | 0 |
| K223528 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-01-20 | 58 | 0 |
| K220628 | LINK Endo-Model EVO Knee System | Waldemar Link GmbH & Co. KG | 2022-05-03 | 60 | 0 |
| K211677 | ELEOS Limb Salvage System | Onkos Surgical | 2021-07-28 | 57 | 0 |
| K211768 | LINK Endo-Model Knee System, Femoral Segments (Augments), UH | Waldemar Link GmbH & Co. KG | 2021-06-30 | 22 | 0 |
| K210010 | GMK Revision & Hinge Extension - TiNbN Coating | Medacta International S.A. | 2021-03-02 | 57 | 0 |
| K192798 | Zimmer Segmental System | Zimmer, Inc. | 2020-12-10 | 437 | 0 |
| K190181 | Instruments for LINK MEGASYSTEM-C Family | LinkBio Corp. | 2019-10-25 | 266 | 0 |
| K191779 | Attune Revision LPS Inserts | Depuy(Ireland) | 2019-10-08 | 98 | 4 |
| K190100 | USTAR II System | United Orthopedic Corporation | 2019-09-23 | 244 | 4 |
| K172347 | GMK Hinge, GMK Revision | Medacta International S.A. | 2017-11-01 | 90 | 0 |
| K163311 | GMK Revision Femoral Distal Augmentation | Medacta International S.A. | 2016-12-21 | 28 | 0 |
| K161520 | ELEOS Limb Salvage System | Onkos Surgical, Inc. | 2016-10-28 | 148 | 8 |
| K152431 | LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link | Waldemar Link GmbH & Co. KG | 2016-05-09 | 257 | 16 |
| K151008 | LINK® MEGASYSTEM-C® | Waldemar Link GmbH & Co. KG | 2015-08-26 | 133 | 16 |
| K151118 | Smith and Nephew Legion Hinge Knee System | Smith & Nephew | 2015-07-28 | 92 | 0 |
| K140900 | PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT | Stanmore Worldwide Implants , Ltd. | 2015-02-12 | 310 | 0 |
| K150028 | Zimmer Segmental System XT Components | Zimmer, Inc. | 2015-02-06 | 30 | 0 |
| K143179 | The LINK® Endo-Model® Knee System | Waldemar Link GmbH & Co. KG | 2015-01-30 | 87 | 7 |
| K140898 | PATIENT SPECIFIC DISTAL FEMORAL | Stanmore Implants Worldwide , Ltd. | 2015-01-20 | 287 | 1 |
| K140509 | BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE | Biomet Manufacturing, LLC | 2014-05-28 | 89 | 0 |
| K133152 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | Stanmore Implants Worldwide , Ltd. | 2014-01-22 | 61 | 0 |
| K131393 | MAK OSS FEMORAL KNEE COMPONENTS | Biomet Orthopedics Corp. | 2013-10-24 | 162 | 0 |
| K130299 | GMK HINGE | Medacta International | 2013-08-15 | 189 | 2 |
| K122015 | DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENT | Howmedica Osteonics Corp. | 2013-02-22 | 227 | 0 |
| K121029 | METS MODULAR DISTAL FEMUR | Stanmore Implants Worldwide , Ltd. | 2012-09-19 | 167 | 0 |
| K120992 | METS SMILES TOTAL KNEE REPLACEMENT | Stanmore Implants Worldwide , Ltd. | 2012-09-05 | 156 | 6 |
| K110940 | ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPO | Zimmer, Inc. | 2011-07-01 | 88 | 0 |
| K092138 | JTS EXTENDEABLE IMPLANT | Stanmore Implants Worldwide , Ltd. | 2011-03-22 | 615 | 0 |
| K101815 | ENDURO KNEE SYSTEM | Aesculap Implant Systems | 2010-12-20 | 173 | 0 |
| K091453 | LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-19872733 | DePuy Orthopaedics, Inc. | 2009-08-12 | 86 | 0 |
| K083779 | MAK OSS KNEE FEMORAL COMPONENTS | Biomet Manufacturing Corp | 2009-04-03 | 105 | 1 |
| K083827 | ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL B | Biomet Manufacturing Corp | 2009-02-13 | 52 | 1 |
| K081111 | LEGION HINGE KNEE SYSTEM | Smith & Nephew, Inc. | 2008-07-23 | 96 | 0 |
| K080330 | SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BOD | Biomet, Inc. | 2008-06-11 | 126 | 0 |
| K072367 | REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR | Wrightmedicaltechnologyinc | 2008-01-09 | 139 | 0 |
| K070978 | ZIMMER SEGMENTAL SYSTEM | Zimmer, Inc. | 2007-07-03 | 88 | 5 |
| K062301 | DEPUY LPS PROXIMAL TIBIAL COMPONENT | DePuy Orthopaedics, Inc. | 2006-10-13 | 66 | 0 |
| K060360 | HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET | Howmedica Osteonics Corp. | 2006-03-15 | 30 | 0 |
| K060131 | OSS-BODIES PROXIMAL TIBIAL SLEEVE | Biomet Manufacturing Corp | 2006-02-15 | 28 | 0 |
| K052685 | ORTHOPEDIC SALVAGE SYSTEM- OSS | Biomet, Inc. | 2005-10-27 | 29 | 2 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda