510(k) Report

Devices descending from K924138

581 later devices reach Osteomed M3 System (SBF System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+7K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+7K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+7K240160EGPS Navigated InstrumentsAstura Medical20240—
+7K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+7K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+7K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+7K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+7K241539Activmotion SNewclip Technics20240—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+7K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+7K223558CUVIS-spineCurexo, Inc.20230—
+7K230204ALPHALOK Plating SystemVilex, LLC20230—
+7K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+7K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+7K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—
+7K221558ALPHALOK Plating SystemVilex, LLC20222—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K221395Footmotion Plating SystemNewclip Technics20220—
+7K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+7K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+7K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+7K213214Xpert WristNewclip Technics20210—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20211—
+7K201569CUVIS-spineCurexo, Inc.20212—
+7K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+7K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+7K203381Dynanail Mini HybridMedShape, Inc.202141
+7K202810AutoStrut G2Orthospin, Ltd.20213—
+7K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+7K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K200226RetroFixRetrofix Screws, LLC20200—
+7K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+7K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+7K193366T2 ICFStryker GmbH20201—
+7K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+7K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+7K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+7K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+7K173641Activ AnkleNewclip Technics20183—
+7K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+7K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+7K172886Breakaway Screw SystemParagon 2820174—
+7K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+7K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+7K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+7K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+7K170843Alians Fragment SpecificNewclip Technics20171—
+7K170771VariAx 2 Foot SystemStryker GmbH20170—
+7K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+7K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+7K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+7K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+7K151769Anchorage 2 CP SystemStryker GmbH20150—
+7K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl201519—
+7K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+8K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+8K262344Large Compression ScrewsTriMed, Inc.20260—
+8K261511Xpert AnkleNewclip Technics20260—
+8K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K260761APTUS Clavicle System 2.8Medartis AG20260—
+8K261241TriMed Compression ScrewsTriMed, Inc.20260—
+8K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+8K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+8K252961Fusion FibFix NailFusion Orthopedics USA, LLC20260—
+8K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+8K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+8K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+8K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—