510(k) Report

Devices descending from K941141

261 later devices reach Precision Ostelock SP Femoral Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+9K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+9K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+9K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+9K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+9K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+9K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+9K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+9K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+9K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+9K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+9K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+9K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+9K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+9K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+9K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+9K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+9K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+9K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+9K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+9K163577Ecofit® Hip SystemImplantcast GmbH201791
+9K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+9K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+9K171156OMNI Anseris Hip StemOmnilife Science20170—
+9K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+9K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+9K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+10K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+10K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+10K252451EPORE® XO cup systemImplantcast GmbH20260—
+10K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+10K251166Mfinity Femoral SystemMedacta International S.A.20250—
+10K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+10K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+10K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+10K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+10K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+10K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+10K210678implaFit® hip stemsImplantcast GmbH20223—
+10K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+10K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+10K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+10K203420EcoFit® Hip SystemImplantcast GmbH20214—
+10K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+10K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+10K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+10K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+10K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+10K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+11K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+11K252401implaFit® short stemsImplantcast GmbH20260—
+11K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+11K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+11K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+11K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+11K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+11K232371Actinia® hip stemsImplantcast GmbH20231—
+11K221104Actera™ hip systemConformis, Inc.202211
+11K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+12K252067Velora Acetabular SystemRestor3D, Inc.20250—
+12K231178ACTERA™ hip systemConformis, Inc.20230—