510(k) Report

Devices descending from K012091

88 later devices reach Pro-Femur through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181—
+1K112080Preserve Hip StemWrightmedicaltechnologyinc20118—
+1K112150Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc20114—
+1K111910Gladiator Hip StemWrightmedicaltechnologyinc20115—
+1K111699Profemur (R) Z Titanium Plasma Sprayed Hip StemWrightmedicaltechnologyinc20113—
+1K111698Profemur (R) E Cementless Hip StemWrightmedicaltechnologyinc201123
+1K110399Gladiator Plasma Classic Hip StemWrightmedicaltechnologyinc20112—
+1K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+1K041850Medallion Modular Hip SystemBiomet Manufacturing, Inc.20041—
+2K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+2K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+2K201519PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc.20201—
+2K200007PROFEMUR GLADIATOR Thin HA Classic Hip Stem with CollarMicroport Orthopedics, Inc.20201—
+2K150133PROFEMUR Preserve Size 1-3 Hip StemsMicroport Orthopedics, Inc.20153—
+2K150302PROFEMUR Preserve Classic StemMicroport Orthopedics, Inc.20154—
+2K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+2K123434Profemur Z Classic StemsWrightmedicaltechnologyinc201321
+2K122778Profemur Z Revision Hip StemWrightmedicaltechnologyinc20120—
+2K121221Profemur Z Revision Hip StemWrightmedicaltechnologyinc20123—
+2K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+2K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+2K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+2K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+2K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+2K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+2K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+3K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+3K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.20220—
+3K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+3K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+3K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+3K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+3K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+3K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+3K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+4K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+4K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+4K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+4K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+5K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+5K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+5K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+5K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+5K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+5K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+5K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+5K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+5K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+5K171249Entrada™ hip stemOrtho Development Corporation20172—
+5K171156OMNI Anseris Hip StemOmnilife Science20170—
+5K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+5K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+6K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+6K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+6K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+6K251166Mfinity Femoral SystemMedacta International S.A.20250—
+6K251052Trivicta® Hip StemOrtho Development Corp.20250—
+6K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+6K241472Icona Hip StemCorin U.S.A. Limited20241—
+6K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+6K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+6K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+6K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+6K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+6K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+6K211703Insignia Hip StemStryker Orthopaedics20217—
+6K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+6K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+6K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+6K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+7K261576Icona Hip StemCorin, Ltd.20260—
+7K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+7K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+7K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+7K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+7K210678implaFit® hip stemsImplantcast GmbH20223—
+7K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+7K221104Actera™ hip systemConformis, Inc.202211
+8K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+8K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+8K252401implaFit® short stemsImplantcast GmbH20260—
+8K252067Velora Acetabular SystemRestor3D, Inc.20250—
+8K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+8K232371Actinia® hip stemsImplantcast GmbH20231—
+8K231178ACTERA™ hip systemConformis, Inc.20230—
+9K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+9K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+9K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—