510(k) Report

Devices descending from K991964

93 later devices reach Eis Threaded Screw Fracture Fixation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050681Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc.200592—
+2K252061Distal Xtremities SystemTriMed, Inc.20250—
+2K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+2K250948TriMed Fusion Cup SystemTriMed, Inc.20250—
+2K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+2K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+2K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+2K111266Easylock OsteosystemTriMed, Inc.20110—
+2K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma200968—
+3K262344Large Compression ScrewsTriMed, Inc.20260—
+3K261241TriMed Compression ScrewsTriMed, Inc.20260—
+3K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+3K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+3K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+3K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+3K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+3K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+3K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+3K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+3K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+3K160058Biomet Variable Pitch Compression Screw SystemBiomet, Inc.20160—
+3K153395OS2-C Compression StapleIn2bones Sas20167—
+3K151407RECON systemNormed Medizin-Technik GmbH20154—
+3K150126Life Spine Cannulated ScrewsLife Spine, Inc.20153—
+3K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+3K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+3K131061Restore Bunion Correction SystemNextremity Solutions201315—
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+4K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+4K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+4K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+4K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+4K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+4K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+4K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+4K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+4K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+4K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+4K163440Stealth Staple SystemFirst Ray, LLC20173—
+4K153065The Hammertoe Correction SystemLife Spine, Inc.20162—
+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
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K143365Eminent Foot Plate SystemEminent Spine20151—
+4K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+5K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+5K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+5K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+5K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+5K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+5K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+5K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+5K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+5K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+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—
+5K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+5K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+5K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+5K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+6K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+6K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+6K233017TM Plating SystemTyber Medical, LLC20231—
+6K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+6K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—