510(k) Report

Devices descending from K961685

430 later devices reach P.F.C. Cruciate Retaining Knee System (Size 1.5) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…Depuy Ireland UC20240—
+1K193057ATTUNE All-Polyethylene TibiaDepuy Ireland UC20200—
+1K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc.20191—
+1K150496Total Knee Arthroplasty SystemResponsive Orthopedics, LLC2015012
+1K103756Depuy Attune Total Knee SystemDePuy Orthopaedics, Inc.20117—
+1K101433Depuy Attune Knee SystemDePuy Orthopaedics, Inc.2010114—
+1K082500Depuy Sigma CR-F Femoral ComponentDePuy Orthopaedics, Inc.2008115—
+1K062654Depuy Sigma Cruciate Retaining Porocoat Femoral ComponentsDePuy Orthopaedics, Inc.2006120—
+1K060192Apex Knee SystemOmni Life Science, Inc.20061111
+1K040166Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc.2004324—
+1K033272Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc.200435151
+1K991106P.F.C. Sigma Porous Modular Keel Tibial TrayDePuy Orthopaedics, Inc.19993—
+1K971652P.F.C. Sigma Inset PatellaJohnson & Johnson Professionals, Inc.19971—
+2K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+2K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc.20260—
+2K242665DePuy ATTUNE™ Total Knee SystemDepuy Orthopedics, Inc.20240—
+2K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+2K200765Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd.20210—
+2K201611Apex Knee SystemOmnilife Science20210—
+2K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized…Depuy Ireland UC202041
+2K201347DePuy ATTUNE™ Total Knee SystemDePuy Orthopaedics, Inc.20200—
+2K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UC20200—
+2K192507LOSPA II Knee SystemCorentec Co., Ltd.20197—
+2K191779Attune Revision LPS InsertsDepuy (Ireland)201904
+2K170806ATTUNE Cemented Tibial Base, Fixed BearingDepuy (Ireland)201721
+2K140881Depuy Attune Knee System - Cementless CR and PS Femoral ComponenetsDepuy (Ireland)2015310
+2K140302Optetrak Logic Porous Femoral ComponentsExactech, Inc.20141—
+2K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+2K112891Apex Revision Knee SystemsOmni Life Science, Inc.201251
+2K112906Klassic Knee SystemTotal Joint Orthopedics, Inc.201233—
+2K111433Depuy Sttune (TM) PS Knee SystemDePuy Orthopaedics, Inc.2011391
+2K111062Apex Knee System, Apex All Poly TibiaOmni Life Science, Inc.20110—
+2K102578Apex PS Knee SystemOmni Life Science, Inc.20118—
+2K101994Apex Knee Modular Tibia SystemOmnlife Science201061
+2K101499Journey CR Knee SystemSmith & Nephew, Inc.201045—
+2K094017Tibial Baseplate Augment Model KC-22118, KC-22128, KC-22138, KC-22148, KC-22158Omni Life Science, Inc.201076
+2K090705Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp.2009421
+2K080842Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc.200861—
+2K073602Modification to: Apex Knee SystemOmnlife Science200872—
+2K061648Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc.2006611
+2K052472Depuy Global Shoulder Crosslink GlenoidDePuy Orthopaedics, Inc.2005158—
+2K003026PFC Sigma Lugged Tibial TrayDePuy Orthopaedics, Inc.20010—
+3K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd.20260—
+3K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+3K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC20260—
+3K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+3K243991Klassic Knee System - Revision Tibial BaseplateTotal Joint Othopedics, Inc.20251—
+3K242401EXULT Knee Replacement SystemCorentec Co., Ltd.20240—
+3K242046EXULT Knee Replacement SystemCorentec Co., Ltd.20242—
+3K240678ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC20240—
+3K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…Depuy Ireland UC20240—
+3K232303ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC202311
+3K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-PostTotal Joint Othopedics, Inc.20230—
+3K230537Klassic Knee Revision SystemTotal Joint Othopedics, Inc.20232—
+3K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+3K222278LOSPA TKR System Instrumentation, EXULT TKR System InstrumentationCorentec Co., Ltd.20220—
+3K213781ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DPDepuy Ireland UC202201
+3K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+3K211602Klassic Knee SystemTotal Joint Orthopedics, Inc.20210—
+3K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+3K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210—
+3K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+3K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+3K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+3K183596Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post…Total Joint Orthopedics, Inc.20192—
+3K181947Persona Revision Knee SystemZimmer, Inc.201841
+3K181794Truliant Porous Femoral ComponentsExactech, Inc.20180—
+3K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+3K180159Klassic® Knee SystemTotal Joint Orthopedics, Inc.201822—
+3K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+3K162422Klassic Knee SystemTotal Joint Orthopedics, Inc.201623—
+3K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc.20160—
+3K160700ATTUNE Revision Knee SystemDepuy (Ireland)201665
+3K153437Apex Revision Knee SystemOmnilife Science201541
+3K153310Klassic Knee SystemTotal Joint Orthopedics, Inc.201524—
+3K153075Klassic Knee SystemTotal Joint Orthopedics, Inc.201524—
+3K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsOrtho Development Corporation20151—
+3K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+3K150105Klassic Knee System-Sombrero PatellaTotal Joint Orthopedics, Inc.201524—
+3K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+3K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+3K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc.201427—
+3K132752Ultracongruent InsertUnited Orthopedic Corporation20145—
+3K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+3K131472Apex Knee Modular Tibia SystemOmni Life Science, Inc.20135—
+3K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A.201314—
+3K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+3K121443Journey II CR Knee SystemSmith & Nephew, Inc.201237—
+3K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.201254
+3K111184Apex PS Knee System - PS-C InsertOmni Life Science, Inc.20112—
+3K110905Total Shoulder SystemShoulder Innovations, LLC20110—
+3K103835Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C…Howmedica Osteonics Corp.2011431
+3K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+3K093056Smith & Nephew, Inc. Journey Select Knee SystemSmith & Nephew, Inc.20099—
+3K092122Global Shoulder Steptech Anchor Peg GlenoidDePuy Orthopaedics, Inc.200975—
+3K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation2008512
+3K070267Depuy GCK Tibial ComponentsDePuy Orthopaedics, Inc.200712—
+3K070849Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc.200759—
+3K060694Modular Hybrid GlenoidBiomet Manufacturing Corp2006574
+4K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—