510(k) Report

Devices descending from K031050

314 later devices reach PCW Percutaneous Compression Wire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+4K181898Two-Step Implant SystemTrilliant Surgical20180—
+4K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+4K180932Diamond Orthopedic Bone Fixation Screws and PinsDiamond Orthopedic, LLC20180—
+4K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+4K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+4K172886Breakaway Screw SystemParagon 2820174—
+4K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+4K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+4K162171S4 Screw System™Subchondral Solutions20173—
+4K170547Arthrex Mesh Plate SystemArthrex, Inc.201715—
+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—
+4K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+4K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+4K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+4K170382Arthrex Compression ScrewsArthrex, Inc.20173—
+4K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+4K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+4K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie20170—
+4K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+4K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+4K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+4K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+4K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+4K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+4K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+4K151407RECON systemNormed Medizin-Technik GmbH20154—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K151146N-Force Fixation SystemInnovision, Inc.20151—
+4K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+4K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+4K150626Rush Medullary PinsZimmer, Inc.20150—
+4K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+4K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+4K142776Flow-ScrewFlow-Fx, LLC20151—
+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
+4K140970One-Piece Peek Fusion ImplantMtp Solutions, LLC20140—
+4K140148Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc201420—
+4K132244N-Force Fixation SystemInnovision, Inc.20143—
+4K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+4K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+4K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+4K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+4K121004Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20122—
+5K262975Arthrex Beaming SystemArthrex, Inc.20260—
+5K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+5K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+5K261511Xpert AnkleNewclip Technics20260—
+5K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+5K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+5K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+5K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+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—
+5K254162KLS Martin Ixos SystemKLS Martin L.P.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—
+5K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+5K243469SignexOsteonic Co., Ltd.20250—
+5K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+5K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+5K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+5K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+5K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho20241—
+5K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+5K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+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—
+5K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+5K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+5K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+5K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+5K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+5K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+5K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+5K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+5K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+5K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+5K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+5K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+5K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+5K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+5K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+5K202307Activ FuseNewclip Technics20200—
+5K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—