510(k) Report

Devices descending from K913231

329 later devices reach S-Rom (TM) Total Lhip System W/Ceramic Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K011489Summit Duofix Hip ProsthesisDePuy Orthopaedics, Inc.200140—
+5K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+5K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+5K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+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—
+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—
+5K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+5K210678implaFit® hip stemsImplantcast GmbH20223—
+5K220216C-Stem AMT LE ProsthesisDepuy Ireland UC20228—
+5K211891DM Converter - TiN coatedMedacta International S.A.20220—
+5K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+5K211703Insignia Hip StemStryker Orthopaedics20217—
+5K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+5K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+5K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+5K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+5K183312Conformity StemUnited Orthopedic Corporation20193—
+5K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+5K182048Avenir Complete Hip SystemZimmer, Inc.20185—
+5K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+5K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+5K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+5K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+5K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+5K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+5K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.201611
+5K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+5K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd.201671
+5K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+5K151902REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc.20157—
+5K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+5K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+5K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+5K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+5K130634Corin Metafix Hip StemCorin USA20135—
+5K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+5K123392Avenir Muller StemZimmer GmbH2013414
+5K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+5K112091H-Max S Femoral Stems, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.20126—
+5K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+5K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+5K112150Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc20114—
+5K111910Gladiator Hip StemWrightmedicaltechnologyinc20115—
+5K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+5K093736Depuy Corail Hip System, Revision StemDePuy Orthopaedics, Inc.201114—
+5K101472Multifit Total Hip SystemOtis Biotech Co., Ltd.20110—
+5K102080Depuy Reclaim Revision Hip SystemDepuy (Ireland)201073
+5K082525Corin Metafix Femoral StemCorin USA2010712
+5K082239Depuy C-Stem AmtDePuy Orthopaedics, Inc.200814—
+5K080991Depuy Asr XL Modular Acetabular Cup SystemDePuy Orthopaedics, Inc.2008041
+6K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+6K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.20260—
+6K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+6K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+6K252401implaFit® short stemsImplantcast GmbH20260—
+6K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+6K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+6K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+6K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+6K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+6K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+6K243466Conformity Stem Extension Line, #0United Orthopedic Corporation20250—
+6K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+6K242249Conformity Stem Extension LineUnited Orthopedic Corporation20241—
+6K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+6K240876Identity Shoulder SystemZimmer, Inc.20241—
+6K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+6K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+6K233476Z1 Hip SystemOrchard Medical Development202421
+6K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+6K232371Actinia® hip stemsImplantcast GmbH20231—
+6K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+6K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+6K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+6K221462DePuy Reclaim Monobloc Revision Femoral StemDepuy Ireland UC20226—
+6K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+6K221104Actera™ hip systemConformis, Inc.202211
+6K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+6K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+6K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+6K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+6K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+6K201519PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc.20201—
+6K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+6K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+6K202484Cordera Hip SystemConformis, Inc.202022
+6K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+6K200007PROFEMUR GLADIATOR Thin HA Classic Hip Stem with CollarMicroport Orthopedics, Inc.20201—
+6K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+6K192189Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc.20194—
+6K193030Avenir Muller Stem, Avenir Cemented Hip StemZimmer GmbH20193—