510(k) Report

Devices descending from K971189

356 later devices reach P.F.C. Sigma 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—
+1K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+1K073529Depuy Sigma PS Femoral ComponentsDePuy Orthopaedics, Inc.200840—
+1K040166Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc.2004324—
+1K033272Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc.200435151
+2K200765Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd.20210—
+2K111433Depuy Sttune (TM) PS Knee SystemDePuy Orthopaedics, Inc.2011391
+2K101433Depuy Attune Knee SystemDePuy Orthopaedics, Inc.2010114—
+2K090705Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp.2009421
+2K061648Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc.2006611
+2K052472Depuy Global Shoulder Crosslink GlenoidDePuy Orthopaedics, Inc.2005158—
+3K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+3K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC20260—
+3K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc.20260—
+3K242665DePuy ATTUNE™ Total Knee SystemDepuy Orthopedics, Inc.20240—
+3K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…Depuy Ireland UC20240—
+3K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+3K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+3K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210—
+3K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized…Depuy Ireland UC202041
+3K201347DePuy ATTUNE™ Total Knee SystemDePuy Orthopaedics, Inc.20200—
+3K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UC20200—
+3K192507LOSPA II Knee SystemCorentec Co., Ltd.20197—
+3K191779Attune Revision LPS InsertsDepuy (Ireland)201904
+3K170806ATTUNE Cemented Tibial Base, Fixed BearingDepuy (Ireland)201721
+3K160700ATTUNE Revision Knee SystemDepuy (Ireland)201665
+3K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsOrtho Development Corporation20151—
+3K140881Depuy Attune Knee System - Cementless CR and PS Femoral ComponenetsDepuy (Ireland)2015310
+3K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+3K132752Ultracongruent InsertUnited Orthopedic Corporation20145—
+3K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A.201314—
+3K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+3K112906Klassic Knee SystemTotal Joint Orthopedics, Inc.201233—
+3K110905Total Shoulder SystemShoulder Innovations, LLC20110—
+3K103835Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C…Howmedica Osteonics Corp.2011431
+3K103756Depuy Attune Total Knee SystemDePuy Orthopaedics, Inc.20117—
+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
+4K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.20260—
+4K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+4K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.20250—
+4K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+4K243991Klassic Knee System - Revision Tibial BaseplateTotal Joint Othopedics, Inc.20251—
+4K242401EXULT Knee Replacement SystemCorentec Co., Ltd.20240—
+4K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd.20242—
+4K242046EXULT Knee Replacement SystemCorentec Co., Ltd.20242—
+4K240678ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC20240—
+4K232303ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC202311
+4K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+4K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-PostTotal Joint Othopedics, Inc.20230—
+4K230537Klassic Knee Revision SystemTotal Joint Othopedics, Inc.20232—
+4K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+4K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+4K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation20220—
+4K222278LOSPA TKR System Instrumentation, EXULT TKR System InstrumentationCorentec Co., Ltd.20220—
+4K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+4K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+4K213781ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DPDepuy Ireland UC202201
+4K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+4K211602Klassic Knee SystemTotal Joint Orthopedics, Inc.20210—
+4K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+4K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+4K191814Alliance GlenoidZimmer, Inc.20194—
+4K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+4K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+4K183596Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post…Total Joint Orthopedics, Inc.20192—
+4K181947Persona Revision Knee SystemZimmer, Inc.201841
+4K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+4K180159Klassic® Knee SystemTotal Joint Orthopedics, Inc.201822—
+4K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+4K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+4K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation20171—
+4K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+4K162422Klassic Knee SystemTotal Joint Orthopedics, Inc.201623—
+4K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc.20160—
+4K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+4K152430All Poly Tibial ComponentUnited Orthopedic Corporation20160—
+4K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+4K153310Klassic Knee SystemTotal Joint Orthopedics, Inc.201524—
+4K153075Klassic Knee SystemTotal Joint Orthopedics, Inc.201524—
+4K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation20153—
+4K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+4K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+4K150105Klassic Knee System-Sombrero PatellaTotal Joint Orthopedics, Inc.201524—
+4K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+4K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+4K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+4K133811Restoris Porous Partial Knee SystemMako Surgical Corp.201419—
+4K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc.201427—
+4K130759Humelock II Cementless Shoulder SystemFx Solutions201331—
+4K123122Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic201356—
+4K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+4K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+4K091196GRS Glenoid Resurfacing SystemArthrosurface, Inc.200923—