ClearanceBrief
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)
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Top companies in KRO

Decided510(k)Device and applicantCode
Aug 6, 2026K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System
Howmedica Osteonics Corp. dba Stryker Orthopaedics
KRO
Dec 15, 2025K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathl
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
KRO
Aug 22, 2025K252303Stem Extension Line (USTAR II System)
United Orthopedic Corporation, TW
KRO
Jul 25, 2025K251665Triathlon® Hinge Knee System
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
KRO
Nov 21, 2024K242871ATTUNE™ Revision Hinge Knee
Depuy Ireland UC, IE
KRO
Apr 1, 2024K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage Sy
Microport Orthopedics, Inc.
KRO
Mar 21, 2024K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Parti
Depuy Ireland UC, IE
KRO
Sep 27, 2023K230563EVOLUTION® Hinge Knee System
Microport Orthopedics, Inc.
KRO
May 19, 2023K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®
Stryker
KRO
Apr 21, 2023K223069Modular Rotating Hinge Knee Systems and Compatible Components
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
KRO
Jan 20, 2023K223528Triathlon® Hinge Knee System
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
KRO
May 3, 2022K220628LINK Endo-Model EVO Knee System
Waldemar Link GmbH & Co. KG, DE
KRO
Jul 28, 2021K211677ELEOS Limb Salvage System
Onkos Surgical
KRO
Jun 30, 2021K211768LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE
Waldemar Link GmbH & Co. KG, DE
KRO
Mar 2, 2021K210010GMK Revision & Hinge Extension - TiNbN Coating
Medacta International S.A., CH
KRO
Dec 10, 2020K192798Zimmer Segmental System
Zimmer, Inc.
KRO
Oct 25, 2019K190181Instruments for LINK MEGASYSTEM-C Family
LinkBio Corp.
KRO
Oct 8, 2019K191779Attune Revision LPS Inserts
Depuy(Ireland), IE
KRO
Sep 23, 2019K190100USTAR II System
United Orthopedic Corporation, TW
KRO
Nov 1, 2017K172347GMK Hinge, GMK Revision
Medacta International S.A., CH
KRO
Dec 21, 2016K163311GMK Revision Femoral Distal Augmentation
Medacta International S.A., CH
KRO
Oct 28, 2016K161520ELEOS Limb Salvage System
Onkos Surgical, Inc.
KRO
May 9, 2016K152431LINK 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, 2015K151008LINK® MEGASYSTEM-C®
Waldemar Link GmbH & Co. KG, DE
KRO
Jul 28, 2015K151118Smith and Nephew Legion Hinge Knee System
Smith & Nephew
KRO
Feb 12, 2015K140900PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT
Stanmore Worldwide Implants , Ltd.
KRO
Feb 6, 2015K150028Zimmer Segmental System XT Components
Zimmer, Inc.
KRO
Jan 30, 2015K143179The LINK® Endo-Model® Knee System
Waldemar Link GmbH & Co. KG, DE
KRO
Jan 20, 2015K140898PATIENT SPECIFIC DISTAL FEMORAL
Stanmore Implants Worldwide , Ltd.
KRO
May 28, 2014K140509BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE
Biomet Manufacturing, LLC
KRO
Jan 22, 2014K133152JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
Stanmore Implants Worldwide , Ltd.
KRO
Oct 24, 2013K131393MAK OSS FEMORAL KNEE COMPONENTS
Biomet Orthopedics Corp.
KRO
Aug 15, 2013K130299GMK HINGE
Medacta International
KRO
Feb 22, 2013K122015DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
Howmedica Osteonics Corp.
KRO
Sep 19, 2012K121029METS MODULAR DISTAL FEMUR
Stanmore Implants Worldwide , Ltd.
KRO
Sep 5, 2012K120992METS SMILES TOTAL KNEE REPLACEMENT
Stanmore Implants Worldwide , Ltd.
KRO
Jul 1, 2011K110940ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN
Zimmer, Inc.
KRO
Mar 22, 2011K092138JTS EXTENDEABLE IMPLANT
Stanmore Implants Worldwide , Ltd.
KRO
Dec 20, 2010K101815ENDURO KNEE SYSTEM
Aesculap Implant Systems
KRO
Aug 12, 2009K091453LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331
DePuy Orthopaedics, Inc.
KRO
Apr 3, 2009K083779MAK OSS KNEE FEMORAL COMPONENTS
Biomet Manufacturing Corp
KRO
Feb 13, 2009K083827ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES
Biomet Manufacturing Corp
KRO
Jul 23, 2008K081111LEGION HINGE KNEE SYSTEM
Smith & Nephew, Inc.
KRO
Jun 11, 2008K080330SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER
Biomet, Inc.
KRO
Jan 9, 2008K072367REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR
Wrightmedicaltechnologyinc
KRO
Jul 3, 2007K070978ZIMMER SEGMENTAL SYSTEM
Zimmer, Inc.
KRO
Oct 13, 2006K062301DEPUY LPS PROXIMAL TIBIAL COMPONENT
DePuy Orthopaedics, Inc.
KRO
Mar 15, 2006K060360HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAPTERS
Howmedica Osteonics Corp.
KRO
Feb 15, 2006K060131OSS-BODIES PROXIMAL TIBIAL SLEEVE
Biomet Manufacturing Corp
KRO
Oct 27, 2005K052685ORTHOPEDIC SALVAGE SYSTEM- OSS
Biomet, Inc.
KRO

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