510(k) Report

Devices descending from K061312

343 later devices reach 36MM Biolox Delta Ceramic Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+4K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+4K232371Actinia® hip stemsImplantcast GmbH20231—
+4K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+4K231925MINIMA S SystemLima Corporate S.P.A.20230—
+4K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+4K213842ONVOY Acetabular SystemGlobus Medical, Inc.20221—
+4K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+4K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K211866Bencox THR SystemCorentec Co., Ltd.20210—
+4K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+4K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+4K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+4K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadZimmer, Inc.20190—
+4K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+4K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+4K190057DJO Acetabular SystemEncore Medical L.P.201925
+4K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+4K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+4K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+4K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+4K183582MPACT ExtensionMedacta International S.A.20194—
+4K181947Persona Revision Knee SystemZimmer, Inc.201841
+4K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+4K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+4K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+4K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+4K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+4K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+4K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+4K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+4K161592Persona Partial Knee SystemBiomet, Inc.201652
+4K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+4K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+4K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+4K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+4K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+4K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+4K150522G7 Dual Mobility SystemBiomet, Inc.2015211
+4K142761Corin TaperFit Hip StemCorin USA201541
+4K143314Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20152—
+4K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517—
+4K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+4K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp.20140—
+4K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+4K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+4K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+4K131647Trinity Acetabular SystemCorin USA201322—
+4K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA2013332
+4K130128Trinity Acetabular SystemCorin Medical201317—
+4K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+4K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+4K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+4K111981Tregor Dual Mobility Acetabular SystemAston Medical20120—
+4K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+4K111911Corin Optimom Modular HeadCorin USA201162—
+4K110555Arcomxl Active ArticulationBiomet Manufacturing Corp2011222
+4K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+5K261453G7® Acetabular SystemZimmer Biomet20260—
+5K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+5K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+5K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+5K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+5K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+5K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+5K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—
+5K251834Persona Partial KneeZimmer Biomet20250—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+5K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+5K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+5K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+5K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+5K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+5K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+5K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+5K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+5K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+5K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+5K230011Mpact ExtensionMedacta International S.A.20233—
+5K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+5K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+5K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+5K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+5K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+5K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+5K212870TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd.20222—
+5K213381Physica systemLima Corporate S.P.A.202101
+5K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc.20211—
+5K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+5K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+5K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+5K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingEncore Medical L.P.202102
+5K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+5K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—