510(k) Report

Devices descending from K052917

178 later devices reach Stryker Compartmental Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160461Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc.20163—
+1K093056Smith & Nephew, Inc. Journey Select Knee SystemSmith & Nephew, Inc.20099—
+1K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation2008512
+1K070695Zimmer Patellofemoral Joint ProsthesisZimmer, Inc.20071225
+1K061648Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc.2006611
+2K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…Depuy Ireland UC20240—
+2K200122MOTO PFJ SystemMedacta International S.A.20202—
+2K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UC20200—
+2K200433iBalance UKA Tibial Tray ImplantArthrex, Inc.20201—
+2K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.201852
+2K171365Arthrex Knee SystemsArthrex, Inc.20170—
+2K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+2K133811Restoris Porous Partial Knee SystemMako Surgical Corp.201419—
+2K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation2009505
+2K073286Gender Solutions Natural-Knee Flex SystemZimmer, Inc.20081175
+2K070267Depuy GCK Tibial ComponentsDePuy Orthopaedics, Inc.200712—
+2K070849Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc.200759—
+3K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.20250—
+3K242307ACHIEVE Partial Knee SystemIgnite Orthomotion20241—
+3K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+3K213071MOTOTM Partial Knee & MOTO PFJ Systems ExtensionMedacta International S.A.20211—
+3K190633NanoOrtho NanoKnee® SystemNanoortho, LLC20190—
+3K190439Engage™ Partial Knee SystemEngage Uni, LLC201954
+3K191625Persona Revision Knee SystemZimmer, Inc.201911
+3K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+3K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+3K181947Persona Revision Knee SystemZimmer, Inc.201841
+3K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017241
+3K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20178—
+3K150410Restoris Porous Partial Knee SystemMako Surgical Corporation20150—
+3K133039Restoris Multicompartmental Knee SystemMako Surgical Corporation201326—
+3K120313Neo CR Knee SystemPipeline Orthopedics20123—
+3K113369Zimmer Persona Knee SystemZimmer, Inc.20129639
+3K110950Consensus Knee SystemConsensus Orthopedics, Inc.201114—
+3K102927Consensus Knee SystemConsensus Orthopedics, Inc.20110—
+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—
+4K251618MOTO Partial Knee System ExtensionMedacta International S.A.20250—
+4K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+4K241180Consensus Knee System with TiNbNShalby Advanced Technologies20251—
+4K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+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—
+4K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+4K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+4K230078TRAX® CR Total Knee SystemAmplitude20230—
+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
+4K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+4K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics202341
+4K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+4K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+4K212129Persona® Personalized Knee SystemZimmer Switzerland Manufacturing GmbH20210—
+4K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+4K210551Persona Revision Knee SystemZimmer, Inc.202101
+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—
+4K200209Persona Personalized Knee SystemZimmer, Inc.20202—
+4K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+4K191996BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20193—
+4K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20194—
+4K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+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—
+4K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+4K173849Triathlon Total Knee SystemStryker Orthopaedics2018143
+4K163167CKS Plus Knee SystemConsensus Orthopedics, Inc.20173—
+4K160515PS2 Knee SystemConsensus Orthopedics, Inc.20162—
+4K150307RESTORIS Multicompartmental Knee SystemMako Surgical Corp.201525—
+4K143725Consensus Knee System Modular Tibial BaseplateConsensus Orthopedics, Inc.20153—
+4K142787Zimmer Persona Personalized Knee SystemZimmer, Inc.201416—
+4K142388Neo Total Knee SystemNew Era Orthopedics, LLC20140—
+4K133919Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc.20147—
+4K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+4K133737Zimmer (R) Persona the Personalized Kee System 14X +30MM Tapered Stem ExtensionZimmer, Inc.20145—
+4K131368Neo Knee SystemPipeline Orthopedics20131—
+4K123692Pipeline Knee SystemPipeline Orthopedics20130—
+4K122500Neo PS Knee SystemPipeline Orthopedics20131—
+4K130143Persona Natural Tibia BaseplatesZimmer, Inc.201321—
+4K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+4K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+4K122745Zimmer Persona the Personalized Knee SystemZimmer, Inc.201221—
+4K122765Persona Natural Tibia BaseplatesZimmer, Inc.2012252
+4K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+4K112285Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / RLP, Uncoated…Tgm Medical, Inc.20111—
+5K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+5K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+5K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+5K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+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