510(k) Report

Devices descending from K933102

154 later devices reach Howmedica Acetabular Shell W/Screw Holes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+7K171249Entrada™ hip stemOrtho Development Corporation20172—
+7K171156OMNI Anseris Hip StemOmnilife Science20170—
+7K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+7K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+7K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+7K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+8K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+8K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+8K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+8K251166Mfinity Femoral SystemMedacta International S.A.20250—
+8K251052Trivicta® Hip StemOrtho Development Corp.20250—
+8K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+8K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+8K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+8K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+8K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+8K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+8K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+8K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+8K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+8K211703Insignia Hip StemStryker Orthopaedics20217—
+8K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+8K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+8K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+8K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+8K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+8K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+8K163577Ecofit® Hip SystemImplantcast GmbH201791
+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—
+10K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+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—