510(k) Report

Devices descending from K062863

310 later devices reach Osteomed Extended 2.0/2.4CANNULATED Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+3K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+3K172886Breakaway Screw SystemParagon 2820174—
+3K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+3K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+3K162171S4 Screw System™Subchondral Solutions20173—
+3K170547Arthrex Mesh Plate SystemArthrex, Inc.201715—
+3K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+3K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+3K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+3K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+3K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+3K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+3K170382Arthrex Compression ScrewsArthrex, Inc.20173—
+3K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+3K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie20170—
+3K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+3K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+3K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+3K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+3K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+3K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+3K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+3K151407RECON systemNormed Medizin-Technik GmbH20154—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K151146N-Force Fixation SystemInnovision, Inc.20151—
+3K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+3K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+3K150626Rush Medullary PinsZimmer, Inc.20150—
+3K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+3K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+3K142776Flow-ScrewFlow-Fx, LLC20151—
+3K143139Arthrex Fracture SystemArthrex, Inc.20151—
+3K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+3K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+3K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+3K140970One-Piece Peek Fusion ImplantMtp Solutions, LLC20140—
+3K140148Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc201420—
+3K132244N-Force Fixation SystemInnovision, Inc.20143—
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+3K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+3K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+3K121004Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20122—
+4K262975Arthrex Beaming SystemArthrex, Inc.20260—
+4K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K261511Xpert AnkleNewclip Technics20260—
+4K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+4K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+4K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+4K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+4K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+4K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+4K254182AsterOsteonic Co., Ltd.20260—
+4K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+4K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+4K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+4K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+4K243469SignexOsteonic Co., Ltd.20250—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+4K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+4K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+4K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho20241—
+4K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+4K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+4K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+4K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+4K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+4K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+4K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+4K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+4K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+4K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+4K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+4K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+4K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+4K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+4K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+4K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+4K202307Activ FuseNewclip Technics20200—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+4K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+4K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+4K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—