510(k) Report

Devices descending from K993082

161 later devices reach Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K252451EPORE® XO cup systemImplantcast GmbH20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—
+5K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+5K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+5K243839Alteon® HA Femoral StemsExactech, Inc.20250—
+5K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+5K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+5K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+5K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+5K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+5K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+5K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+5K231178ACTERA™ hip systemConformis, Inc.20230—
+5K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+5K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+5K221104Actera™ hip systemConformis, Inc.202211
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+5K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+5K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+5K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+5K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+5K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+5K203420EcoFit® Hip SystemImplantcast GmbH20214—
+5K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+5K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+5K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+5K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+5K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+5K170473C2 femoral stemLima Corporate S.P.A.20170—
+5K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+5K160011H-Max S stemLima Corporate S.P.A.20161—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+6K251052Trivicta® Hip StemOrtho Development Corp.20250—
+6K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+6K243809Biolox® Delta Revision headsLimacorporate20250—
+6K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+6K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+6K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+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—
+6K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+6K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+6K163577Ecofit® Hip SystemImplantcast GmbH201791
+6K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+7K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+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—
+8K252401implaFit® short stemsImplantcast GmbH20260—
+8K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+8K232371Actinia® hip stemsImplantcast GmbH20231—
+8K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—