510(k) Report

Devices descending from K032151

118 later devices reach Depuy Sigma Tibial Inserts and CO-CR Tibial Trays through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…Depuy Ireland UC20240—
+1K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc.20191—
+1K170806ATTUNE Cemented Tibial Base, Fixed BearingDepuy (Ireland)201721
+1K150496Total Knee Arthroplasty SystemResponsive Orthopedics, LLC2015012
+1K101433Depuy Attune Knee SystemDePuy Orthopaedics, Inc.2010114—
+2K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+2K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC20260—
+2K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc.20260—
+2K242665DePuy ATTUNE™ Total Knee SystemDepuy Orthopedics, Inc.20240—
+2K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…Depuy Ireland UC20240—
+2K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+2K200765Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd.20210—
+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—
+2K193057ATTUNE All-Polyethylene TibiaDepuy Ireland UC20200—
+2K192507LOSPA II Knee SystemCorentec Co., Ltd.20197—
+2K191779Attune Revision LPS InsertsDepuy (Ireland)201904
+2K140881Depuy Attune Knee System - Cementless CR and PS Femoral ComponenetsDepuy (Ireland)2015310
+2K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+2K111433Depuy Sttune (TM) PS Knee SystemDePuy Orthopaedics, Inc.2011391
+2K103756Depuy Attune Total Knee SystemDePuy Orthopaedics, Inc.20117—
+3K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+3K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+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—
+3K232303ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC202311
+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—
+3K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+3K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+3K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+3K181947Persona Revision Knee SystemZimmer, Inc.201841
+3K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+3K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+3K160700ATTUNE Revision Knee SystemDepuy (Ireland)201665
+3K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+3K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+3K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+3K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+4K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.20260—
+4K250889EXULT Knee Replacement SystemCorentec Co., Ltd.20250—
+4K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+4K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+4K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+4K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+4K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+4K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd.20242—
+4K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+4K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+4K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+4K213381Physica systemLima Corporate S.P.A.202101
+4K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+4K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+4K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+4K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+4K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+4K191625Persona Revision Knee SystemZimmer, Inc.201911
+4K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+4K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+4K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+4K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+5K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts20260—
+5K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+5K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+5K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—
+5K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+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—
+5K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+5K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+5K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+5K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+5K230078TRAX® CR Total Knee SystemAmplitude20230—
+5K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+5K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+5K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+5K211938Physica LMC Knee SystemLimacorporate20210—
+5K210551Persona Revision Knee SystemZimmer, Inc.202101
+5K201084Physica systemLima Corporate S.P.A.20205—
+5K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+5K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+5K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+5K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+5K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+5K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+6K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+6K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+6K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+6K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+6K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+6K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+6K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+6K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+6K210554Physica systemLima Corporate S.P.A.20212—
+6K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+6K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174