510(k) Report

Devices descending from K921274

644 later devices reach Metallic Toatal Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K170473C2 femoral stemLima Corporate S.P.A.20170—
+5K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+5K161635AMIStem-H Proximal CoatingMedacta International S.A.201710—
+5K160011H-Max S stemLima Corporate S.P.A.20161—
+5K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20160—
+5K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+5K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+5K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+5K143009Echo Bi-Metric Microplasty Hip SystemBiomet, Inc.20141—
+5K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+5K141653Biolox Delta Ceramic Option HeadsBiomet, Inc.20144—
+5K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+5K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+5K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+5K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—
+5K131518Mectacer Biolox Option HeadsMedacta International20130—
+5K131684Biolox (R) Delta Ceramic HeadsBiomet, Inc.201392
+5K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+5K131884Avenir Cemented Hip StemZimmer GmbH20131—
+5K122160Vanguard XP Knee SystemBiomet Manufacturing Corp2013612
+5K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+5K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132—
+5K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201333—
+5K121874G7 Acetabular SystemBiomet Manufacturing Corp2012533
+5K122529Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc.201215—
+5K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+5K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+5K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp201214—
+5K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.201288—
+5K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp2012467
+5K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+5K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+5K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+5K091956Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P.20101194
+5K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010140—
+5K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc.20072173
+6K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+6K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.20260—
+6K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+6K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+6K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+6K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+6K252067Velora Acetabular SystemRestor3D, Inc.20250—
+6K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+6K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+6K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+6K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+6K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+6K241241Z1 Cemented Hip SystemOrchard Medical Development, LLC20240—
+6K240876Identity Shoulder SystemZimmer, Inc.20241—
+6K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+6K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+6K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+6K233476Z1 Hip SystemOrchard Medical Development202421
+6K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+6K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+6K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+6K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+6K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+6K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+6K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+6K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+6K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+6K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+6K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+6K222380TriVerse Total Knee Replacement SystemSignature Orthopaedics Pty, Ltd.20221—
+6K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+6K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+6K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+6K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+6K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+6K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+6K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+6K210554Physica systemLima Corporate S.P.A.20212—
+6K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+6K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+6K201084Physica systemLima Corporate S.P.A.20205—
+6K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+6K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+6K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+6K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+6K192683Biolox delta Ceramic Heads, Biolox delta Option Ceramic HeadsBiomet UK, Ltd.20202—
+6K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+6K191831MobiliT CupCorin U.S.A. Limited20203—
+6K192189Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc.20194—
+6K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+6K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+6K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+6K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadZimmer, Inc.20190—
+6K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+6K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+6K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+6K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+6K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+6K190057DJO Acetabular SystemEncore Medical L.P.201925
+6K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+6K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+6K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+6K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—