510(k) Report

Devices descending from K020791

336 later devices reach HBS Headless Bone Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142707AIS Odontoid Fracture Fixation SystemAesculap Implant System, Inc.20143—
+1K132910Depuy Synthes Spine Dens Access SystemSynthes USA Products, LLC20134—
+1K101030Modification to HBS Headless Bone ScrewBiopro, Inc.2010402
+1K030706Ebi Dynafix Compression Bone ScrewEbi, L.P.200369—
+1K024233Kompressor Screw SystemKinetikos Medical, Inc.2003299—
+2K192744CORRIDOR Fixation SystemGlobus Medical, Inc.20192—
+2K142528AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mmAgent Medical, LLC20140—
+2K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.2012391
+2K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma200968—
+2K081934Extremity Medical Compression ScrewExtremity Medical, LLC200868—
+2K040356Kompressor Screw SystemKinetikos Medical, Inc.2004255—
+3K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev420250—
+3K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+3K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+3K183104Mini Cannulated Headed and Headless Screw SetStryker GmbH20190—
+3K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+3K160058Biomet Variable Pitch Compression Screw SystemBiomet, Inc.20160—
+3K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+3K150126Life Spine Cannulated ScrewsLife Spine, Inc.20153—
+3K131061Restore Bunion Correction SystemNextremity Solutions201315—
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K130298Biopro Kwick-Wire Universal Screw SystemBiopro, Inc.20132—
+3K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+3K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+3K101700IO Fix Hand, IO Fix Foot, Extremity Medical Screw SystemExtremity Medical, LLC2010562
+3K082934Extremity Medical Midfoot Screw SystemExtremity Medical, LLC200963—
+3K060071Nexa Compression ScrewNexa Orthopedics, Inc.2006251—
+4K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+4K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+4K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+4K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+4K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+4K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+4K190830TDM Screw SystemsTdm Co., Ltd.20191—
+4K190586Monster® Screw SystemParagon 28, Inc.201921—
+4K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+4K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+4K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+4K162171S4 Screw System™Subchondral Solutions20173—
+4K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+4K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+4K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+4K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+4K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+4K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+4K153065The Hammertoe Correction SystemLife Spine, Inc.20162—
+4K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+4K151407RECON systemNormed Medizin-Technik GmbH20154—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K142581APTUS Foot SystemMedartis AG201522—
+4K143365Eminent Foot Plate SystemEminent Spine20151—
+4K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+4K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+4K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+4K140875Optossol Compression Device SystemGenossis, LLC20140—
+4K121417XMCP, Hallux, Tarsx, Extremity Medical Screw SystemExtremity Medical, LLC20122—
+4K121349IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and WasherExtremity Medical, LLC201212—
+4K093770Extremity Medical Screw SystemExtremity Medical, LLC20103—
+4K091577Extremity Medical Midfoot Screw System, Charcx, Intramedullary Screw SystemExtremity Medical, LLC20094—
+4K073159Trauson Bone Screw, Models HA 3.5 and 4.5Trauson (Jiangsu) Medical Instrument Co., Ltd.20083—
+4K063298Osteomed Headless Cannulated Screw SystemOsteomed LP2007246—
+5K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+5K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+5K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+5K231860TDM Screw SystemTdm Co., Ltd.20240—
+5K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+5K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+5K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+5K230744Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC20231—
+5K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+5K221342REDEMPTION Beaming SystemVilex, LLC20220—
+5K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+5K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+5K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+5K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+5K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+5K203011Monster Screw SystemParagon 28, Inc.20206—
+5K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+5K202680OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemOsteomed, LLC20207—
+5K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+5K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+5K200124InCore MPJ SystemNextremity Solutions, Inc.20200—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K192578InCore TMT SystemNextremity Solutions, Inc.20191—
+5K191636APTUS Foot SystemMedartis AG20190—
+5K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K180257InCore® Lapidus SystemNextremity Solutions, Inc.20183—
+5K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+5K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+5K170056IRENE Cannulated Screw SystemTianjin Zhengtian Medical Instrument Co., Ltd.20170—
+5K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+5K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+5K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+5K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—