510(k) Report

Devices descending from K903362

228 later devices reach Osteolock (TM) Acetabular Cup through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+6K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+6K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+6K240487EVOS Patella PlatesSmith & Nephew20240—
+6K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+6K233017TM Plating SystemTyber Medical, LLC20231—
+6K230011Mpact ExtensionMedacta International S.A.20233—
+6K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+6K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+6K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+6K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+6K200391MPACT ExtensionMedacta International S.A.20210—
+6K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+6K191358Trident II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20196—
+6K183582MPACT ExtensionMedacta International S.A.20194—
+6K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+6K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+6K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+6K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+6K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+6K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+6K143453Mpact Double Mobility SystemMedacta International20151—
+6K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+6K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+6K132879Mpact ExtensionMedacta International201411—
+6K131986Corin Minihip StemCorin USA20133—
+6K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+6K131458Mpact DM Liner ConverterMedacta International20133—
+6K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+6K122911Versafitcup CC Trio ExtensionMedacta International20121—
+6K122641Mpact ExtensionMedacta International201214—
+6K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+6K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+6K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+6K111145Endo HeadMedacta International20110—
+6K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+6K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+6K103518Trinity Acetabular SystemCorin USA20118—
+7K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+7K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+7K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+7K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+7K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+7K241472Icona Hip StemCorin U.S.A. Limited20241—
+7K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+7K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+7K211891DM Converter - TiN coatedMedacta International S.A.20220—
+7K220376Acetabular Dome Hole PlugHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+7K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+7K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+7K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+7K173746Activmotion RangeNewclip Technics20181—
+7K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+7K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+7K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+7K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+7K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+7K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+8K261576Icona Hip StemCorin, Ltd.20260—
+8K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+8K241539Activmotion SNewclip Technics20240—
+8K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+8K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+8K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+8K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+8K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+8K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+8K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+8K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+8K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+8K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+8K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+8K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+8K171249Entrada™ hip stemOrtho Development Corporation20172—
+8K171156OMNI Anseris Hip StemOmnilife Science20170—
+8K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+8K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+8K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+9K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+9K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+9K251166Mfinity Femoral SystemMedacta International S.A.20250—
+9K251052Trivicta® Hip StemOrtho Development Corp.20250—
+9K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+9K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+9K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+9K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+9K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+9K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+9K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+9K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+9K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+9K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+9K211703Insignia Hip StemStryker Orthopaedics20217—
+9K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+9K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+9K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+9K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+9K191936iNSitu Total Hip SystemThecken Companies, LLC20192—