510(k) Report

Devices descending from K990197

164 later devices reach Modulus Compatible Stability (MCS)-HA Total Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+5K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+5K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+5K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+5K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+5K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+5K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+5K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+5K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+5K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+6K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+6K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+6K252451EPORE® XO cup systemImplantcast GmbH20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+6K252067Velora Acetabular SystemRestor3D, Inc.20250—
+6K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+6K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+6K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+6K241472Icona Hip StemCorin U.S.A. Limited20241—
+6K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+6K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+6K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+6K231178ACTERA™ hip systemConformis, Inc.20230—
+6K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+6K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+6K221104Actera™ hip systemConformis, Inc.202211
+6K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+6K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+6K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+6K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+6K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+6K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+6K203420EcoFit® Hip SystemImplantcast GmbH20214—
+6K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+6K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+6K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+6K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+6K170473C2 femoral stemLima Corporate S.P.A.20170—
+6K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+6K160011H-Max S stemLima Corporate S.P.A.20161—
+7K261576Icona Hip StemCorin, Ltd.20260—
+7K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+7K243809Biolox® Delta Revision headsLimacorporate20250—
+7K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+7K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+7K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+7K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+7K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+7K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+7K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+7K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+7K163577Ecofit® Hip SystemImplantcast GmbH201791
+7K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+8K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+8K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+8K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+8K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+8K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+8K210678implaFit® hip stemsImplantcast GmbH20223—
+9K252401implaFit® short stemsImplantcast GmbH20260—
+9K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+9K232371Actinia® hip stemsImplantcast GmbH20231—
+9K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—