510(k) Report

Devices descending from K993768

224 later devices reach Citation TMZF HA Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+8K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+9K252451EPORE® XO cup systemImplantcast GmbH20260—
+9K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+9K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+9K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+9K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+9K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+9K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+9K210678implaFit® hip stemsImplantcast GmbH20223—
+9K221104Actera™ hip systemConformis, Inc.202211
+9K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+9K203420EcoFit® Hip SystemImplantcast GmbH20214—
+9K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+9K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+9K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+10K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+10K252401implaFit® short stemsImplantcast GmbH20260—
+10K252067Velora Acetabular SystemRestor3D, Inc.20250—
+10K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+10K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+10K232371Actinia® hip stemsImplantcast GmbH20231—
+10K231178ACTERA™ hip systemConformis, Inc.20230—
+10K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—