510(k) Report

Devices descending from K950761

481 later devices reach Index Acetabulat Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K243809Biolox® Delta Revision headsLimacorporate20250—
+7K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+7K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+7K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+7K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+7K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+7K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+7K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+7K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+7K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+7K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+7K241472Icona Hip StemCorin U.S.A. Limited20241—
+7K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+7K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+7K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+7K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+7K230120KeYi Total Knee SystemBeijing Keyi Medical Device Technology Co., Ltd.20240—
+7K233093Balanced Knee® System TriMax PS Plus Tibial InsertOrtho Development Corporation20230—
+7K230011Mpact ExtensionMedacta International S.A.20233—
+7K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+7K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+7K231925MINIMA S SystemLima Corporate S.P.A.20230—
+7K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+7K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+7K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+7K210678implaFit® hip stemsImplantcast GmbH20223—
+7K212870TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd.20222—
+7K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+7K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+7K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+7K213381Physica systemLima Corporate S.P.A.202101
+7K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+7K211938Physica LMC Knee SystemLimacorporate20210—
+7K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+7K203420EcoFit® Hip SystemImplantcast GmbH20214—
+7K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.20200—
+7K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+7K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+7K200151Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial…Zimmer, Inc.20200—
+7K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+7K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+7K191625Persona Revision Knee SystemZimmer, Inc.201911
+7K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+7K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+7K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+7K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+7K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+7K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+7K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+7K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+7K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+7K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+7K173723EMPOWR Universal Tibial BaseplateEncore Medical L.P.201821
+7K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc.20182—
+7K172651FMP Extended LinersEncore Medical L.P.20173—
+7K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+7K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+7K171991EMPOWR Porous Knee SystemEncore Medical L.P.201713
+7K170573Empowr CR Knee Tibial InsertEncore Medical L.P.20170—
+7K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+7K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+7K162222GENflex2 Total Knee SystemStelkast, Inc.20163—
+7K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+7K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+7K160342EMPOWR PS Knee SystemEncore Medical L.P.201665
+7K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsOrtho Development Corporation20151—
+7K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+7K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+7K142761Corin TaperFit Hip StemCorin USA201541
+7K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+7K140130X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree Hooded…Encore Medical L.P.20141—
+7K140830Exprt Revision KneeEncore Medical L.P.201471
+7K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+7K141006RSP Humeral Socket InsertDjo Global2014212
+7K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+7K132158Novohip Total Hip SystemNovosource, Inc.201461
+7K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+7K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+7K131647Trinity Acetabular SystemCorin USA201322—
+7K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+7K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+7K130128Trinity Acetabular SystemCorin Medical201317—
+7K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+7K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+7K121835Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella with VEEncore Medical L.P.20120—
+7K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+7K111936Ortho Devlopment Ceramic Femoral HeadOrtho Development20110—
+7K111911Corin Optimom Modular HeadCorin USA201162—
+7K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+7K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+8K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+8K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+8K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+8K261576Icona Hip StemCorin, Ltd.20260—
+8K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+8K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.20260—
+8K252401implaFit® short stemsImplantcast GmbH20260—
+8K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+8K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+8K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—