510(k) Report

Devices descending from K941366

241 later devices reach Osteonics Omnifit AD-HA Hip Stem Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+5K181693SMS Femoral StemMedacta International S.A.20184—
+5K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+5K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+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—
+5K140915Excia Total Hip SystemAesculap Implant Systems, LLC20142—
+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—
+5K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+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—
+6K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+6K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+6K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+6K243809Biolox® Delta Revision headsLimacorporate20250—
+6K241472Icona Hip StemCorin U.S.A. Limited20241—
+6K212327M-Vizion MonoblocMedacta International S.A.20221—
+6K220376Acetabular Dome Hole PlugHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+6K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+6K203041SMS Cementless StemMedacta International S.A.20201—
+6K201673SMS Cementless StemMedacta International S.A.20203—
+6K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+6K191816M-Vizion Femoral Revision System ExtensionMedacta International S.A.20204—
+6K191781Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis SystemZimmer GmbH20191—
+6K170690M-Vizion Femoral Revision SystemMedacta International S.A.20175—
+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—
+6K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+6K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+6K141327Minima S SystemLima Corporate S.P.A.20145—
+6K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+6K131986Corin Minihip StemCorin USA20133—
+6K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+6K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+6K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+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—
+7K261576Icona Hip StemCorin, Ltd.20260—
+7K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+7K231925MINIMA S SystemLima Corporate S.P.A.20230—
+7K201471M-Vizion Femoral Revision System ExtensionMedacta International S.A.20213—
+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—
+7K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+7K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+7K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+7K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+7K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+8K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+8K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+8K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+8K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+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—
+8K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+8K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+8K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+8K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+8K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+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
+8K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+9K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+9K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+9K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—