510(k) Report

Devices descending from K954935

326 later devices reach S-Rom Femoral Hip Stem - Size 14 X 8 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K131458Mpact DM Liner ConverterMedacta International20133—
+4K130634Corin Metafix Hip StemCorin USA20135—
+4K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+4K123392Avenir Muller StemZimmer GmbH2013414
+4K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+4K112091H-Max S Femoral Stems, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.20126—
+4K122911Versafitcup CC Trio ExtensionMedacta International20121—
+4K122641Mpact ExtensionMedacta International201214—
+4K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+4K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+4K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+4K112150Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc20114—
+4K111910Gladiator Hip StemWrightmedicaltechnologyinc20115—
+4K111145Endo HeadMedacta International20110—
+4K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+4K110947Apex K1 Hip StemOmni Life Science, Inc.20116—
+4K093736Depuy Corail Hip System, Revision StemDePuy Orthopaedics, Inc.201114—
+4K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+4K101472Multifit Total Hip SystemOtis Biotech Co., Ltd.20110—
+4K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+4K102080Depuy Reclaim Revision Hip SystemDepuy (Ireland)201073
+4K082525Corin Metafix Femoral StemCorin USA2010712
+4K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+4K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+4K082239Depuy C-Stem AmtDePuy Orthopaedics, Inc.200814—
+4K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+4K080991Depuy Asr XL Modular Acetabular Cup SystemDePuy Orthopaedics, Inc.2008041
+5K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+5K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+5K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+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—
+5K251166Mfinity Femoral SystemMedacta International S.A.20250—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+5K251052Trivicta® Hip StemOrtho Development Corp.20250—
+5K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+5K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+5K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+5K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+5K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+5K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+5K243466Conformity Stem Extension Line, #0United Orthopedic Corporation20250—
+5K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+5K242249Conformity Stem Extension LineUnited Orthopedic Corporation20241—
+5K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+5K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+5K233476Z1 Hip SystemOrchard Medical Development202421
+5K232371Actinia® hip stemsImplantcast GmbH20231—
+5K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+5K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+5K221462DePuy Reclaim Monobloc Revision Femoral StemDepuy Ireland UC20226—
+5K221104Actera™ hip systemConformis, Inc.202211
+5K211891DM Converter - TiN coatedMedacta International S.A.20220—
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+5K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+5K211703Insignia Hip StemStryker Orthopaedics20217—
+5K201519PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc.20201—
+5K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+5K202484Cordera Hip SystemConformis, Inc.202022
+5K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+5K200007PROFEMUR GLADIATOR Thin HA Classic Hip Stem with CollarMicroport Orthopedics, Inc.20201—
+5K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+5K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+5K192189Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc.20194—
+5K193030Avenir Muller Stem, Avenir Cemented Hip StemZimmer GmbH20193—
+5K192198Conformis Hip SystemConformis, Inc.2019121
+5K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+5K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+5K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+5K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181—
+5K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+5K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+5K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+5K170473C2 femoral stemLima Corporate S.P.A.20170—
+5K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+5K161635AMIStem-H Proximal CoatingMedacta International S.A.201710—
+5K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+5K160011H-Max S stemLima Corporate S.P.A.20161—
+5K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+5K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+5K152530UCP StemUnited Orthopedic Corporation20162—
+5K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+5K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+5K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+5K141327Minima S SystemLima Corporate S.P.A.20145—
+5K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+5K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+5K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+5K131952Corin Metafix Hip StemCorin USA20134—
+5K131884Avenir Cemented Hip StemZimmer GmbH20131—
+5K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+5K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+5K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+5K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—