510(k) Report

Devices descending from K000760

238 later devices reach Reach Femoral Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+6K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+6K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+6K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+6K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+6K163577Ecofit® Hip SystemImplantcast GmbH201791
+6K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+6K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+6K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+6K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+6K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+7K252451EPORE® XO cup systemImplantcast GmbH20260—
+7K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+7K251052Trivicta® Hip StemOrtho Development Corp.20250—
+7K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+7K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+7K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+7K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+7K231178ACTERA™ hip systemConformis, Inc.20230—
+7K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+7K210678implaFit® hip stemsImplantcast GmbH20223—
+7K221104Actera™ hip systemConformis, Inc.202211
+7K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+7K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+7K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+7K203420EcoFit® Hip SystemImplantcast GmbH20214—
+7K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+7K171156OMNI Anseris Hip StemOmnilife Science20170—
+8K252401implaFit® short stemsImplantcast GmbH20260—
+8K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+8K232371Actinia® hip stemsImplantcast GmbH20231—
+8K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+9K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+9K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+9K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+9K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+10K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+10K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—