510(k) Report

Devices descending from K032396

505 later devices reach Ringloc 36MM Line and Modular Femoral Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K153657Vanguard XP Knee SystemBiomet, Inc.201611
+5K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+5K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+5K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+5K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+5K143242Rebel 3DKNEE SystemEncore Medical L.P.20151117
+5K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+5K143635KINETIS Total Knee SystemMako Surgical20150—
+5K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517—
+5K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+5K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp.20140—
+5K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+5K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+5K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.201421
+5K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+5K141327Minima S SystemLima Corporate S.P.A.20145—
+5K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+5K140257Signature Planner, Signature GuidesMaterialise NV20140—
+5K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+5K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+5K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+5K132873Vanguard XP Knee SystemBiomet, Inc.2013322
+5K131337Balanced Knee System High Flex Vitamin E PS Tibial Insert and PatellaOrtho Development Corp.20133—
+5K130365X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P.201338—
+5K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+5K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201330—
+5K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+5K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.201330—
+5K123692Pipeline Knee SystemPipeline Orthopedics20130—
+5K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+5K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+5K123982Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+Encore Medical L.P.201335—
+5K121727Movation Knee SystemEncore Medical L.P.201214—
+5K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly…Encore Medical L.P.2012351
+5K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International201114—
+5K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+5K103120Corin Biolox Delta Femoral HeadsCorin USA2011110—
+5K103223Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P.201037—
+5K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+5K083762Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2009149—
+5K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+6K261453G7® Acetabular SystemZimmer Biomet20260—
+6K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+6K262057GMK ExtensionMedacta International SA20260—
+6K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+6K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+6K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+6K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+6K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+6K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.20250—
+6K251834Persona Partial KneeZimmer Biomet20250—
+6K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+6K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+6K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+6K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+6K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+6K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+6K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+6K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+6K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+6K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+6K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+6K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+6K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+6K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+6K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+6K230120KeYi Total Knee SystemBeijing Keyi Medical Device Technology Co., Ltd.20240—
+6K233093Balanced Knee® System TriMax PS Plus Tibial InsertOrtho Development Corporation20230—
+6K230011Mpact ExtensionMedacta International S.A.20233—
+6K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+6K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+6K231925MINIMA S SystemLima Corporate S.P.A.20230—
+6K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+6K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+6K210678implaFit® hip stemsImplantcast GmbH20223—
+6K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+6K212870TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd.20222—
+6K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+6K213381Physica systemLima Corporate S.P.A.202101
+6K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+6K211938Physica LMC Knee SystemLimacorporate20210—
+6K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+6K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.20200—
+6K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+6K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+6K200151Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial…Zimmer, Inc.20200—
+6K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+6K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+6K191625Persona Revision Knee SystemZimmer, Inc.201911
+6K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+6K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+6K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+6K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+6K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+6K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+6K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+6K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174