510(k) Report

Devices descending from K941141

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+5K221323Exactech® Alteon® Short Tapered WedgeExactech, Inc.20230—
+5K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+5K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+5K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K220405Amis K LongMedacta International S.A.20220—
+5K211866Bencox THR SystemCorentec Co., Ltd.20210—
+5K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+5K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+5K190100USTAR II SystemUnited Orthopedic Corporation201925
+5K191374Revival Modular Hip StemCorin U.S.A. Limited20193—
+5K190057DJO Acetabular SystemEncore Medical L.P.201925
+5K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+5K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+5K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+5K171768Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20171012
+5K170845MiniMAXMedacta International S.A.201771
+5K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc.20170—
+5K161610EXPRT Revision Hip SystemEncore Medical L.P.20161—
+5K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics201611—
+5K151739Revision Femoral StemLima Corporate S.P.A.20157—
+5K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+5K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+5K120595Unisyn Plus Hip StemConsensus Orthopedics, Inc.20120—
+5K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+5K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213—
+5K113556Wagner Cone Prosthesis SystemZimmer GmbH201291
+5K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+5K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc.20093—
+5K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+5K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.200883—
+5K071583Cermet Iii Acetabular Cup SystemImplants International, Ltd.20070—
+5K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+6K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+6K250450Coated hip implantsMedacta International S.A.20250—
+6K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+6K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+6K251052Trivicta® Hip StemOrtho Development Corp.20250—
+6K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+6K243809Biolox® Delta Revision headsLimacorporate20250—
+6K212327M-Vizion MonoblocMedacta International S.A.20221—
+6K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+6K191816M-Vizion Femoral Revision System ExtensionMedacta International S.A.20204—
+6K191358Trident II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20196—
+6K192352MiniMAXMedacta International S.A.20192—
+6K191781Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis SystemZimmer GmbH20191—
+6K181693SMS Femoral StemMedacta International S.A.20184—
+6K170690M-Vizion Femoral Revision SystemMedacta International S.A.20175—
+6K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+6K163497EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal…Encore Medical L.P.201701
+6K161226Revision Femoral StemLima Corporate S.P.A.20170—
+6K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+6K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH20168—
+6K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+6K141327Minima S SystemLima Corporate S.P.A.20145—
+6K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+6K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+6K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+6K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+6K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+6K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+6K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+6K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+6K083312Minihip StemCorin USA201015—
+6K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+6K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+6K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+6K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc.20082—
+6K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+7K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+7K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+7K231925MINIMA S SystemLima Corporate S.P.A.20230—
+7K220376Acetabular Dome Hole PlugHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+7K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+7K201471M-Vizion Femoral Revision System ExtensionMedacta International S.A.20213—
+7K203041SMS Cementless StemMedacta International S.A.20201—
+7K201673SMS Cementless StemMedacta International S.A.20203—
+7K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+7K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+7K170473C2 femoral stemLima Corporate S.P.A.20170—
+7K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+7K160011H-Max S stemLima Corporate S.P.A.20161—
+7K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+7K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+7K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+7K131986Corin Minihip StemCorin USA20133—
+7K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+7K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+7K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+7K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+7K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+7K103518Trinity Acetabular SystemCorin USA20118—
+8K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+8K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+8K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+8K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+8K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481