510(k) Report

Devices descending from K070849

59 later devices reach Depuy GCK Femoral and Tibial Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…Depuy Ireland UC20240—
+1K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UC20200—
+1K093056Smith & Nephew, Inc. Journey Select Knee SystemSmith & Nephew, Inc.20099—
+1K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation2008512
+2K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+2K133811Restoris Porous Partial Knee SystemMako Surgical Corp.201419—
+2K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation2009505
+3K242307ACHIEVE Partial Knee SystemIgnite Orthomotion20241—
+3K190633NanoOrtho NanoKnee® SystemNanoortho, LLC20190—
+3K190439Engage™ Partial Knee SystemEngage Uni, LLC201954
+3K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+3K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+3K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017241
+3K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20178—
+3K160461Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc.20163—
+3K150410Restoris Porous Partial Knee SystemMako Surgical Corporation20150—
+3K133039Restoris Multicompartmental Knee SystemMako Surgical Corporation201326—
+4K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+4K251975Achieve Partial Knee System - Porous Coated CoCrMo Femoral ComponentIgnite Orthomotion20250—
+4K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+4K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20243—
+4K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+4K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+4K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+4K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker20233—
+4K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+4K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics202341
+4K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+4K203341ACS LD Uni FB Knee SystemImplantcast GmbH20211—
+4K203099Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20201—
+4K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+4K200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon…Howmedica Osteonics Corp.20200—
+4K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+4K200433iBalance UKA Tibial Tray ImplantArthrex, Inc.20201—
+4K191996BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20193—
+4K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20194—
+4K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)201911—
+4K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal AugmentHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)201904
+4K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20197—
+4K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20183—
+4K173849Triathlon Total Knee SystemStryker Orthopaedics2018143
+4K171365Arthrex Knee SystemsArthrex, Inc.20170—
+4K150307RESTORIS Multicompartmental Knee SystemMako Surgical Corp.201525—
+5K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+5K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202501
+5K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.20250—
+5K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+5K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+5K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+5K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.20220—
+5K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+5K212307BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+5K203697BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20212—
+5K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+6K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+6K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+6K211895BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—