510(k) Report

Devices descending from K050124

138 later devices reach Porous Coated Acetabular Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+6K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+6K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+6K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+6K250450Coated hip implantsMedacta International S.A.20250—
+6K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+6K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+6K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+6K243809Biolox® Delta Revision headsLimacorporate20250—
+6K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+6K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+6K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+6K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+6K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+6K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+6K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+6K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+6K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+6K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+6K163577Ecofit® Hip SystemImplantcast GmbH201791
+6K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+7K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+7K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+7K241472Icona Hip StemCorin U.S.A. Limited20241—
+7K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+7K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+7K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+7K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+7K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+7K210678implaFit® hip stemsImplantcast GmbH20223—
+8K261576Icona Hip StemCorin, Ltd.20260—
+8K252401implaFit® short stemsImplantcast GmbH20260—
+8K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+8K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+8K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+8K232371Actinia® hip stemsImplantcast GmbH20231—
+8K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—