510(k) Report

Devices descending from K024233

299 later devices reach Kompressor Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+5K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+5K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+5K124027Monster Screw SystemApogee Orthosolutions201341—
+5K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+5K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets20129—
+5K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+5K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+5K102528N-Force Fixation SystemInnovision, Inc.20115—
+5K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH20118—
+5K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+5K101254Newfix Screw, Wire and Pin Fixarion SystemTecnologia Y Diseno Industrial, S.A DE C.V20101—
+6K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+6K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+6K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+6K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+6K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+6K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+6K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+6K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+6K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho20241—
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K233017TM Plating SystemTyber Medical, LLC20231—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+6K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+6K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+6K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+6K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+6K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+6K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+6K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+6K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+6K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K192592Axis Plating SystemExtremity Medical, LLC20190—
+6K190830TDM Screw SystemsTdm Co., Ltd.20191—
+6K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+6K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+6K182677DynaNail MiniMedShape, Inc.20195—
+6K182989AURORA™ Screw SystemMiRus, LLC20180—
+6K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+6K180932Diamond Orthopedic Bone Fixation Screws and PinsDiamond Orthopedic, LLC20180—
+6K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+6K162171S4 Screw System™Subchondral Solutions20173—
+6K171651Excelsius GPSGlobus Medical, Inc.2017691
+6K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+6K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+6K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+6K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+6K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+6K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+6K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+6K150871ForeFoot STP SystemTornier, Inc.20150—
+6K151146N-Force Fixation SystemInnovision, Inc.20151—
+6K151418Monster Screw SystemParagon 28201527—
+6K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+6K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+6K150626Rush Medullary PinsZimmer, Inc.20150—
+6K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+6K142776Flow-ScrewFlow-Fx, LLC20151—
+6K132244N-Force Fixation SystemInnovision, Inc.20143—
+6K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+6K121004Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20122—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped20260—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+7K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+7K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+7K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K240160EGPS Navigated InstrumentsAstura Medical20240—
+7K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+7K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—