510(k) Report

Devices descending from K103705

219 later devices reach Low Profile Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+1K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+1K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+1K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+1K201235Arthrex MaxForce MTP Compression Plates and ScrewsArthrex, Inc.20200—
+1K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+1K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+1K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+1K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+1K143614Arthrex Low Profile ScrewsArthrex, Inc.201519—
+1K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+1K133662Smith & Nephew Cannulated Captured ScrewSmith & Nephew, Inc.20148—
+1K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+1K132911I.B.S Snap-Off Screw / Solafix Snap-Off ScrewIn2bones Sas20140—
+1K132217Arthrex Compression FT ScrewsArthrex, Inc.201318—
+1K131186Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSynthes (USA) Products, LLC20138—
+1K131061Restore Bunion Correction SystemNextremity Solutions201315—
+1K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+1K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+1K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+1K112437Arthrex Fracture SystemArthrex, Inc.201191—
+1K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011135—
+2K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+2K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+2K254215Arthrex Beaming SystemArthrex, Inc.20261—
+2K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+2K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+2K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+2K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+2K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+2K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+2K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+2K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+2K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+2K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+2K230546SignexOsteonic Co., Ltd.20242—
+2K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+2K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+2K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+2K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+2K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+2K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+2K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+2K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+2K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+2K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+2K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+2K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+2K200226RetroFixRetrofix Screws, LLC20200—
+2K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+2K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+2K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+2K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+2K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+2K172886Breakaway Screw SystemParagon 2820174—
+2K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+2K162171S4 Screw System™Subchondral Solutions20173—
+2K170547Arthrex Mesh Plate SystemArthrex, Inc.201715—
+2K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+2K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+2K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+2K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+2K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K170382Arthrex Compression ScrewsArthrex, Inc.20173—
+2K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+2K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie20170—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+2K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+2K151407RECON systemNormed Medizin-Technik GmbH20154—
+2K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+2K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+2K143139Arthrex Fracture SystemArthrex, Inc.20151—
+2K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+2K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+2K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+2K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+2K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+2K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+3K262975Arthrex Beaming SystemArthrex, Inc.20260—
+3K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+3K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+3K261511Xpert AnkleNewclip Technics20260—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+3K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+3K254182AsterOsteonic Co., Ltd.20260—
+3K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+3K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+3K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—