510(k) Report

Devices descending from K013534

241 later devices reach Self-Countersinking Bone Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma200968—
+1K024086Propeller Head Small Cannulated Screw SystemBiomet Orthopedics, Inc.2003171—
+1K022952Modular Head Bone ScrewBiomet, Inc.20020—
+2K160058Biomet Variable Pitch Compression Screw SystemBiomet, Inc.20160—
+2K150126Life Spine Cannulated ScrewsLife Spine, Inc.20153—
+2K131061Restore Bunion Correction SystemNextremity Solutions201315—
+2K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+2K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+2K081813Universal Compression Fracture Repair SystemU.S. Implant Solutions, LLC20094—
+2K082874Biodrive Cannulated Screw SystemBiomet Trauma2009168—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+3K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+3K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+3K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+3K200291CREED™ Cannulated ScrewsGlw Medical, Inc.20202—
+3K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+3K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+3K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+3K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+3K170594I.B.S. osteosynthesis screwsIn2bones Sas20171—
+3K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+3K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+3K153065The Hammertoe Correction SystemLife Spine, Inc.20162—
+3K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+3K151407RECON systemNormed Medizin-Technik GmbH20154—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K143365Eminent Foot Plate SystemEminent Spine20151—
+3K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+3K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp201481
+3K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+3K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+3K140891Biomet Cannulated Screw SystemBiomet, Inc.2014165
+3K140018TSP Hip Fracture Plating SystemBiomet, Inc.201412
+3K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine20101431
+4K254280F.A.S.T ScrewSteps Ortho20260—
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+4K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+4K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+4K223847CREED™ Cannulated ScrewsGlw, Inc.20230—
+4K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+4K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+4K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+4K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+4K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+4K213199Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw SystemStryker GmbH20222—
+4K213301InCore Subtalar SystemNextremity Solutions, Inc.20210—
+4K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+4K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+4K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+4K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+4K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+4K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+4K173826THP Hip Fracture Plating SystemBiomet, Inc.20180—
+4K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+4K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+4K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+4K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+4K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+4K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+5K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+5K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+5K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+5K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+5K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+5K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+5K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+5K192592Axis Plating SystemExtremity Medical, LLC20190—
+5K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+5K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+5K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+5K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+6K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+6K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K240715Idys® C ZP 3DTiClariance20240—
+6K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+6K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+6K233017TM Plating SystemTyber Medical, LLC20231—
+6K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+6K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—