510(k) Report

Devices descending from K041906

145 later devices reach Exactech 12/14 Total Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+5K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+5K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+5K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+5K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+5K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+5K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+5K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+5K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+5K182099Delta TT ProLima Corporate S.P.A.20183—
+5K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+5K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+5K163577Ecofit® Hip SystemImplantcast GmbH201791
+5K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+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
+6K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+6K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+6K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+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—
+6K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+6K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+6K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+6K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+6K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+6K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+6K210678implaFit® hip stemsImplantcast GmbH20223—
+6K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+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—
+6K160011H-Max S stemLima Corporate S.P.A.20161—
+7K252401implaFit® short stemsImplantcast GmbH20260—
+7K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+7K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+7K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+7K232371Actinia® hip stemsImplantcast GmbH20231—
+7K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+7K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+8K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—