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
+5K241483ceramys™ femoral head systemEncore Medical L.P.20251—
+5K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+5K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+5K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+5K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+5K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+5K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+5K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+5K203420EcoFit® Hip SystemImplantcast GmbH20214—
+5K202484Cordera Hip SystemConformis, Inc.202022
+5K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+5K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+5K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+5K191831MobiliT CupCorin U.S.A. Limited20203—
+5K192198Conformis Hip SystemConformis, Inc.2019121
+5K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+5K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+5K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+5K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+5K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+5K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+5K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+5K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+5K170473C2 femoral stemLima Corporate S.P.A.20170—
+5K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+5K160011H-Max S stemLima Corporate S.P.A.20161—
+5K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+5K141653Biolox Delta Ceramic Option HeadsBiomet, Inc.20144—
+5K131518Mectacer Biolox Option HeadsMedacta International20130—
+5K131684Biolox (R) Delta Ceramic HeadsBiomet, Inc.201392
+5K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+5K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+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
+5K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.201288—
+5K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp2012467
+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—
+6K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+6K252067Velora Acetabular SystemRestor3D, Inc.20250—
+6K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+6K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+6K243809Biolox® Delta Revision headsLimacorporate20250—
+6K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+6K241472Icona Hip StemCorin U.S.A. Limited20241—
+6K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+6K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+6K231178ACTERA™ hip systemConformis, Inc.20230—
+6K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+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—
+6K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+6K221104Actera™ hip systemConformis, Inc.202211
+6K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+6K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+6K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+6K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+6K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+6K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+6K210554Physica systemLima Corporate S.P.A.20212—
+6K201084Physica systemLima Corporate S.P.A.20205—
+6K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+6K192683Biolox delta Ceramic Heads, Biolox delta Option Ceramic HeadsBiomet UK, Ltd.20202—
+6K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+6K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+6K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadZimmer, Inc.20190—
+6K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+6K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+6K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+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—
+6K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+6K183582MPACT ExtensionMedacta International S.A.20194—
+6K181761Zimmer Biomet Select Ceramic HeadsZimmer, Inc.20180—
+6K181947Persona Revision Knee SystemZimmer, Inc.201841
+6K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+6K180493A3 Total Knee SystemBeijing AK Medical Co., Ltd.20181—
+6K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+6K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+6K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+6K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+6K163577Ecofit® Hip SystemImplantcast GmbH201791
+6K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+6K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+6K171156OMNI Anseris Hip StemOmnilife Science20170—
+6K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.201754
+6K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—