510(k) Report

Devices descending from K001448

150 later devices reach Trident Acetabular Shells: PS-HA through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+6K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+6K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+7K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+7K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+7K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+7K251166Mfinity Femoral SystemMedacta International S.A.20250—
+7K251052Trivicta® Hip StemOrtho Development Corp.20250—
+7K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+7K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+7K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+7K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+7K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+7K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+7K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+7K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+7K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+7K211703Insignia Hip StemStryker Orthopaedics20217—
+7K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+7K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+7K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+7K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+7K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+7K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+7K163577Ecofit® Hip SystemImplantcast GmbH201791
+7K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+7K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+8K252451EPORE® XO cup systemImplantcast GmbH20260—
+8K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+8K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+8K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+8K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+8K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+8K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+8K210678implaFit® hip stemsImplantcast GmbH20223—
+8K221104Actera™ hip systemConformis, Inc.202211
+8K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+8K203420EcoFit® Hip SystemImplantcast GmbH20214—
+8K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+8K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+8K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+9K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+9K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+9K252401implaFit® short stemsImplantcast GmbH20260—
+9K252067Velora Acetabular SystemRestor3D, Inc.20250—
+9K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+9K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+9K232371Actinia® hip stemsImplantcast GmbH20231—
+9K231178ACTERA™ hip systemConformis, Inc.20230—
+9K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—