510(k) Report

Devices descending from K000538

172 later devices reach Mallory/Head Lateralized Press-Fit Femoral through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063544Modification to Pyrenees Cervical Plate SystemK2m, Inc.200738—
+1K021403HA Mallory/Head Porous Femoral Stem & HA Mallory/Head Porous Lateralized Femoral StemBiomet Orthopedics, Inc.2002132—
+2K153526Pyrenees Cervical Plate SystemK2m20166—
+2K152281Pyrenees Cervical Plate SystemK2m20156—
+2K152015Pyrenees Cervical Plate SystemK2m, Inc.20150—
+2K150983Pyrenees Cervical Plate SystemK2m20157—
+2K142212Pyrenees Cervical Plate SystemK2m, Inc.20150—
+2K113329K2M, Pyrenees Cervical Plate SystemK2m, Inc.201228—
+2K111135Pyrenees Cervical Plate System (Translational Plates)K2m, Inc.20111—
+2K092474Pyrenees Cervical Plate System, Semi-Constrained ScrewsK2m, Inc.20108—
+2K043123Apex Modular HA Hip StemApex Surgical, LLC2005131—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K223321Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC20230—
+3K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+3K172104Ozark (tm) Cervical Plate SystemK2m, Inc.20175—
+3K171156OMNI Anseris Hip StemOmnilife Science20170—
+3K162664Pyrenees Cervical Plate SystemK2m, Inc.20165—
+3K130202Iris Anterior Cervical PlateLife Spine, Inc.201321—
+3K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+3K080842Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc.200861—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+4K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+4K152282Cam Lock Plating SystemLife Spine, Inc.20151—
+4K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+4K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+4K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+4K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+4K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+4K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+4K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+4K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+5K243369Cervical Plating SystemLife Spine, Inc.20240—
+5K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+5K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+5K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+5K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+5K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+5K190016Lateral Plate SystemCorelink, LLC201915—
+5K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+5K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+5K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+5K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+5K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+5K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+5K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+5K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+5K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+5K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+6K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+6K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+6K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+6K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+6K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+6K240876Identity Shoulder SystemZimmer, Inc.20241—
+6K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+6K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+6K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+6K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+6K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+6K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+6K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+6K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+6K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+6K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+6K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+6K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+6K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+6K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+6K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+6K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+7K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+7K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+7K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+7K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+7K250644MSS - Monobloc stemMedacta International S.A.202611
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+7K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+7K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+7K241043Augment Off-Axis Instrument SystemFix Surgical202415
+7K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+7K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+7K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+7K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+7K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+7K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+7K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+7K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+7K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+7K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+7K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+7K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+7K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+7K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+7K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+7K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—