510(k) Report

Devices descending from K792022

988 later devices reach Herbert Bone Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+4K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+4K162171S4 Screw System™Subchondral Solutions20173—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation20174—
+4K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+4K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+4K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+4K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+4K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+4K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+4K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+4K163440Stealth Staple SystemFirst Ray, LLC20173—
+4K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+4K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+4K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+4K161864ARIX Foot SystemJeil Medical Corporation20165—
+4K153065The Hammertoe Correction SystemLife Spine, Inc.20162—
+4K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+4K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+4K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+4K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+4K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+4K150871ForeFoot STP SystemTornier, Inc.20150—
+4K151146N-Force Fixation SystemInnovision, Inc.20151—
+4K151418Monster Screw SystemParagon 28201527—
+4K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+4K143730GBR SystemJeil Medical Corporation20152—
+4K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+4K150626Rush Medullary PinsZimmer, Inc.20150—
+4K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+4K143365Eminent Foot Plate SystemEminent Spine20151—
+4K142776Flow-ScrewFlow-Fx, LLC20151—
+4K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+4K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+4K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+4K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+4K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+4K132244N-Force Fixation SystemInnovision, Inc.20143—
+4K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+4K130298Biopro Kwick-Wire Universal Screw SystemBiopro, Inc.20132—
+4K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+4K123672Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)Inion OY201317—
+4K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+4K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+4K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+4K121004Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20122—
+4K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+4K101700IO Fix Hand, IO Fix Foot, Extremity Medical Screw SystemExtremity Medical, LLC2010562
+4K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+4K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+4K082934Extremity Medical Midfoot Screw SystemExtremity Medical, LLC200963—
+4K081392Bioretec Activascrew, Activascrew Cannulated and Activascrew Cannulated with ActivapinBioretec, Ltd.20082—
+4K062980ActivascrewBioretec, Ltd.20061—
+4K062617Modification to Inion Otps Biodegradable Fixation SystemInion, Ltd.20063—
+4K053561Bio-Mini Revo Suture AnchorConmed Linvatec200675—
+4K060071Nexa Compression ScrewNexa Orthopedics, Inc.2006251—
+4K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc.2005306—
+4K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…Linvatec Biomaterials, Ltd.200476—
+5K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261057ActivaScrew™ Cannulated COMBioretec, Ltd.20260—
+5K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped20260—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+5K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+5K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K253727Syndesmosis TightRope PROArthrex, Inc.20250—
+5K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+5K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+5K251569Bone ScrewOsstem Implant Co., Ltd.20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+5K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+5K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+5K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+5K240487EVOS Patella PlatesSmith & Nephew20240—
+5K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+5K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—