510(k) Report

Devices descending from K974558

508 later devices reach Salvage/Onocology Hip and Total Femur System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K161592Persona Partial Knee SystemBiomet, Inc.201652
+6K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+6K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+6K153657Vanguard XP Knee SystemBiomet, Inc.201611
+6K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+6K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+6K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+6K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+6K143242Rebel 3DKNEE SystemEncore Medical L.P.20151117
+6K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+6K143635KINETIS Total Knee SystemMako Surgical20150—
+6K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517—
+6K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+6K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp.20140—
+6K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+6K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+6K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.201421
+6K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+6K141327Minima S SystemLima Corporate S.P.A.20145—
+6K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+6K140257Signature Planner, Signature GuidesMaterialise NV20140—
+6K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+6K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+6K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+6K132873Vanguard XP Knee SystemBiomet, Inc.2013322
+6K131337Balanced Knee System High Flex Vitamin E PS Tibial Insert and PatellaOrtho Development Corp.20133—
+6K130365X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P.201338—
+6K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+6K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201330—
+6K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+6K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.201330—
+6K123692Pipeline Knee SystemPipeline Orthopedics20130—
+6K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+6K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+6K123982Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+Encore Medical L.P.201335—
+6K121727Movation Knee SystemEncore Medical L.P.201214—
+6K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly…Encore Medical L.P.2012351
+6K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International201114—
+6K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+6K103120Corin Biolox Delta Femoral HeadsCorin USA2011110—
+6K103223Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P.201037—
+6K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+6K083762Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2009149—
+6K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+7K261453G7® Acetabular SystemZimmer Biomet20260—
+7K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+7K262057GMK ExtensionMedacta International SA20260—
+7K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+7K261576Icona Hip StemCorin, Ltd.20260—
+7K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+7K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+7K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+7K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+7K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+7K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.20250—
+7K251834Persona Partial KneeZimmer Biomet20250—
+7K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+7K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+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—
+7K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+7K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+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—
+7K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+7K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+7K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+7K210678implaFit® hip stemsImplantcast GmbH20223—
+7K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+7K212870TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd.20222—
+7K210614BENCOX Mirabo Z Cup CortiniumCorentec 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—
+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—