510(k) Report

Devices descending from K040907

249 later devices reach Arthrex Small Fragment Plates and Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+4K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+4K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+4K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+4K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+4K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+4K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+4K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+4K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+4K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+4K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+4K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+4K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+4K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+4K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+4K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K200226RetroFixRetrofix Screws, LLC20200—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+4K192592Axis Plating SystemExtremity Medical, LLC20190—
+4K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+4K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+4K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+4K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+4K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+4K162171S4 Screw System™Subchondral Solutions20173—
+4K170547Arthrex Mesh Plate SystemArthrex, Inc.201715—
+4K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+4K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+4K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+4K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+4K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+4K170382Arthrex Compression ScrewsArthrex, Inc.20173—
+4K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+4K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie20170—
+4K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+4K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+4K151407RECON systemNormed Medizin-Technik GmbH20154—
+4K143139Arthrex Fracture SystemArthrex, Inc.20151—
+4K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+4K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+4K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+4K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+4K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+5K262975Arthrex Beaming SystemArthrex, Inc.20260—
+5K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+5K261511Xpert AnkleNewclip Technics20260—
+5K260761APTUS Clavicle System 2.8Medartis AG20260—
+5K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+5K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+5K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+5K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+5K254182AsterOsteonic Co., Ltd.20260—
+5K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+5K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+5K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+5K243469SignexOsteonic Co., Ltd.20250—
+5K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+5K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+5K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+5K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+5K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+5K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+5K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+5K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+5K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+5K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+5K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+5K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K210159IntraLock SystemFusion Orthopedics, LLC20210—
+5K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+5K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+5K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+5K202307Activ FuseNewclip Technics20200—
+5K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+5K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+5K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+5K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+5K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+5K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+5K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+5K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—