510(k) Report

Devices descending from K960279

312 later devices reach Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181947Persona Revision Knee SystemZimmer, Inc.201841
+1K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.201852
+1K160157LOSPA Modular Knee SystemCorentec Co., Ltd.201682
+1K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+1K122183Augment and Screw, Psa TypeUnited Orthopedic Corp.201310—
+1K113369Zimmer Persona Knee SystemZimmer, Inc.20129639
+1K111433Depuy Sttune (TM) PS Knee SystemDePuy Orthopaedics, Inc.2011391
+1K083772Columbus Revision Knee SystemAesculap Implant System, Inc.2009124
+1K082424United U2 Total Knee SystemUnited Orthopedic Corp.2008152
+1K081023Evolis Total Knee SystemMedacta International S.A.2008781
+1K031061Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc.200319324
+1K994128Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp.20001398
+1K984158P.F.C. Modular Plus Offset Tibial TrayDepuy, Inc.19997—
+2K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC20260—
+2K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc.20260—
+2K252725Stem Extension Line (U2 Total Knee System—PSA Type)United Orthopedic Corporation20250—
+2K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+2K243817Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202522
+2K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+2K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…Depuy Ireland UC20240—
+2K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…Depuy Ireland UC20240—
+2K230078TRAX® CR Total Knee SystemAmplitude20230—
+2K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+2K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+2K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+2K222278LOSPA TKR System Instrumentation, EXULT TKR System InstrumentationCorentec Co., Ltd.20220—
+2K213381Physica systemLima Corporate S.P.A.202101
+2K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+2K212129Persona® Personalized Knee SystemZimmer Switzerland Manufacturing GmbH20210—
+2K210695CPM Medical Consultants Tibial Revision Knee SystemCpm Medical Consultants, LLC20210—
+2K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+2K201347DePuy ATTUNE™ Total Knee SystemDePuy Orthopaedics, Inc.20200—
+2K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+2K200209Persona Personalized Knee SystemZimmer, Inc.20202—
+2K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+2K192507LOSPA II Knee SystemCorentec Co., Ltd.20197—
+2K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc.20191—
+2K191779Attune Revision LPS InsertsDepuy (Ireland)201904
+2K190100USTAR II SystemUnited Orthopedic Corporation201925
+2K191625Persona Revision Knee SystemZimmer, Inc.201911
+2K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+2K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation20171—
+2K161360U2 Total Knee System, PSA Tibial InsertUnited Orthopedic Corporation20170—
+2K160700ATTUNE Revision Knee SystemDepuy (Ireland)201665
+2K140881Depuy Attune Knee System - Cementless CR and PS Femoral ComponenetsDepuy (Ireland)2015310
+2K142787Zimmer Persona Personalized Knee SystemZimmer, Inc.201416—
+2K142069GMK ExtensionMedacta International20144—
+2K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+2K133737Zimmer (R) Persona the Personalized Kee System 14X +30MM Tapered Stem ExtensionZimmer, Inc.20145—
+2K131864U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation20145—
+2K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+2K131310GMK Full PE Tibial ComponentsMedacta International20132—
+2K123692Pipeline Knee SystemPipeline Orthopedics20130—
+2K122160Vanguard XP Knee SystemBiomet Manufacturing Corp2013612
+2K130143Persona Natural Tibia BaseplatesZimmer, Inc.201321—
+2K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+2K122745Zimmer Persona the Personalized Knee SystemZimmer, Inc.201221—
+2K122765Persona Natural Tibia BaseplatesZimmer, Inc.2012252
+2K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+2K122985Columbus Revision Knee SystemAesculap Implant System, Inc.201201
+2K113060Unity Toatal Knee SystemCorin USA201283
+2K121416GMK SphereMedacta International201220—
+2K120790GMK - Line ExtensionMedacta International201211—
+2K113571GMK Resufacing Patella Size 4Medacta International201223—
+2K111283GMK Revision Hybrid LinersMedacta International20110—
+2K094013HLS Kneetec SystemTornier20111—
+2K101815Enduro Knee SystemAesculap Implant Systems201010—
+2K100981United Stem, Psa TypeUnited Orthopedic Corp.20103—
+2K090988GMK Total Knee SystemMedacta International S.A.2009521
+2K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+2K072619Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF) Porous…Zimmer, Inc.20071024
+2K072160Nexgen Trabecular Metal Tibial TrayZimmer, Inc.20071081
+2K043101Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem ExtensionsZimmer, Inc.20055922
+2K041100Nexgen Porous, HA/TCP, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc.200463
+2K042271Nexgen Complete Knee Solution LPS-Flex Prolong Highly Crosslinked Polyethylene Articular…Zimmer, Inc.2004162
+2K032079HLS Noetos SystemTornier20030—
+2K030367Columbus (PS)Aesculap, Inc.2003171
+2K021313Search Evolution Total Knee SystemAesculap, Inc.2002120—
+2K013906HLS Noetos SystemTornier20023—
+3K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd.20260—
+3K262057GMK ExtensionMedacta International SA20260—
+3K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.20260—
+3K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+3K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+3K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+3K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202501
+3K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+3K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+3K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+3K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+3K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+3K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+3K242401EXULT Knee Replacement SystemCorentec Co., Ltd.20240—
+3K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd.20242—
+3K242046EXULT Knee Replacement SystemCorentec Co., Ltd.20242—
+3K240875Unity Knee PS-C Tibial InsertCorin U.S.A. Limited20240—
+3K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+3K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—