510(k) Report

Devices descending from K050681

92 later devices reach Omnitech System & Easy Lock Osteosystem with Xtremities Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252061Distal Xtremities SystemTriMed, Inc.20250—
+1K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+1K250948TriMed Fusion Cup SystemTriMed, Inc.20250—
+1K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+1K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+1K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+1K111266Easylock OsteosystemTriMed, Inc.20110—
+1K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma200968—
+2K262344Large Compression ScrewsTriMed, Inc.20260—
+2K261241TriMed Compression ScrewsTriMed, Inc.20260—
+2K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+2K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+2K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+2K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+2K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+2K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+2K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K160058Biomet Variable Pitch Compression Screw SystemBiomet, Inc.20160—
+2K153395OS2-C Compression StapleIn2bones Sas20167—
+2K151407RECON systemNormed Medizin-Technik GmbH20154—
+2K150126Life Spine Cannulated ScrewsLife Spine, Inc.20153—
+2K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+2K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+2K131061Restore Bunion Correction SystemNextremity Solutions201315—
+2K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+3K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+3K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+3K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+3K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+3K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+3K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+3K163440Stealth Staple SystemFirst Ray, LLC20173—
+3K153065The Hammertoe Correction SystemLife Spine, Inc.20162—
+3K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+3K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+3K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K143365Eminent Foot Plate SystemEminent Spine20151—
+3K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+4K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+4K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+4K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+4K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+4K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+4K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+4K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+5K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+5K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—