510(k) Report

Devices descending from K800806

118 later devices reach I.C.S. Mini & Small Fragment Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991873Kmi Wrist Fusion SystemKinetikos Medical, Inc.1999117—
+2K131380Acumed Totalw Rist Fusion Plating SystemAcumed, LLC20130—
+2K1032432.4MM VA-LCP Intercarpal Fusion SystemSynthes (Usa)2011187
+2K100123Acumed Wrist Arthrodesis Plate SystemAcumed, LLC20101—
+2K093163Integra Total Wrist Fusion SystemIntegra LifeSciences Corporation20090—
+2K050681Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc.200592—
+2K030881Avanta Carpal Fusion Plating SystemAvanta Orthopaedics, Inc.20030—
+2K021321Wrist Fusion PlateAcu Med, Inc.2002113—
+3K252061Distal Xtremities SystemTriMed, Inc.20250—
+3K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+3K250948TriMed Fusion Cup SystemTriMed, Inc.20250—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+3K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+3K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+3K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+3K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+3K111266Easylock OsteosystemTriMed, Inc.20110—
+3K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma200968—
+4K262344Large Compression ScrewsTriMed, Inc.20260—
+4K261241TriMed Compression ScrewsTriMed, Inc.20260—
+4K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+4K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+4K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+4K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+4K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+4K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+4K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+4K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+4K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+4K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+4K160058Biomet Variable Pitch Compression Screw SystemBiomet, Inc.20160—
+4K153395OS2-C Compression StapleIn2bones Sas20167—
+4K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+4K151407RECON systemNormed Medizin-Technik GmbH20154—
+4K150126Life Spine Cannulated ScrewsLife Spine, Inc.20153—
+4K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+4K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+4K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+4K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+4K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+4K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+4K131061Restore Bunion Correction SystemNextremity Solutions201315—
+4K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+4K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+5K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+5K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+5K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+5K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+5K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+5K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+5K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+5K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+5K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+5K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+5K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+5K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+5K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+5K163440Stealth Staple SystemFirst Ray, LLC20173—
+5K153065The Hammertoe Correction SystemLife Spine, Inc.20162—
+5K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+5K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+5K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+5K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K143365Eminent Foot Plate SystemEminent Spine20151—
+5K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+6K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+6K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+6K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+6K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+6K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+6K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+6K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+6K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+6K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+6K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+6K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+6K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+6K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+6K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+6K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+6K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+7K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+7K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—