510(k) Report

Devices descending from K944592

327 later devices reach Precision Osteolock Femoral Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K040412Trident T Acetabular ShellsStryker Orthopaedics200423—
+4K032380Wagner Cone ProsthesisCenterpulse Orthopedics, Inc.200324—
+5K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+5K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+5K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+5K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+5K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+5K243444Bioceram Azul® HeadKyocera Corporation20240—
+5K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+5K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+5K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+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—
+5K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+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—
+5K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+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—
+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—
+5K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+5K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+5K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+5K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga20141—
+5K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+5K120595Unisyn Plus Hip StemConsensus Orthopedics, Inc.20120—
+5K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+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—
+5K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+5K113556Wagner Cone Prosthesis SystemZimmer GmbH201291
+5K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+5K103721Mpact Acetabular SystemMedacta International201121—
+5K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+5K103352Versafitcup CC TrioMedacta International20114—
+5K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+5K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+5K083312Minihip StemCorin USA201015—
+5K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+5K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+5K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+5K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc.20082—
+5K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+5K071583Cermet Iii Acetabular Cup SystemImplants International, Ltd.20070—
+6K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+6K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+6K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+6K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+6K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+6K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+6K250450Coated hip implantsMedacta International S.A.20250—
+6K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+6K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+6K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+6K241461Mpact Constrained LinerMedacta International S.A.20251—
+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—
+6K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+6K243809Biolox® Delta Revision headsLimacorporate20250—
+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—
+6K212327M-Vizion MonoblocMedacta International S.A.20221—
+6K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+6K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+6K200391MPACT ExtensionMedacta International S.A.20210—
+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—
+6K183582MPACT ExtensionMedacta International S.A.20194—
+6K181693SMS Femoral StemMedacta International S.A.20184—
+6K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+6K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—