510(k) Report

Devices descending from K971854

216 later devices reach Osteolock Acetabular Shell System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+5K143453Mpact Double Mobility SystemMedacta International20151—
+5K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+5K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+5K132879Mpact ExtensionMedacta International201411—
+5K131986Corin Minihip StemCorin USA20133—
+5K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+5K131458Mpact DM Liner ConverterMedacta International20133—
+5K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+5K122911Versafitcup CC Trio ExtensionMedacta International20121—
+5K122641Mpact ExtensionMedacta International201214—
+5K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+5K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+5K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+5K111145Endo HeadMedacta International20110—
+5K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+5K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+5K103518Trinity Acetabular SystemCorin USA20118—
+6K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+6K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+6K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+6K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+6K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+6K241472Icona Hip StemCorin U.S.A. Limited20241—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+6K211891DM Converter - TiN coatedMedacta International S.A.20220—
+6K220376Acetabular Dome Hole PlugHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+6K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+6K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+6K173746Activmotion RangeNewclip Technics20181—
+6K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+6K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+6K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+6K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+6K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+6K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+6K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+7K261576Icona Hip StemCorin, Ltd.20260—
+7K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+7K241539Activmotion SNewclip Technics20240—
+7K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+7K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+7K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+7K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+7K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+7K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+7K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+7K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+7K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+7K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+7K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+7K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+7K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+7K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+7K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+7K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+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—
+8K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+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—
+9K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+9K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+9K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+9K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+9K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—