510(k) Report

Devices descending from K052614

245 later devices reach Low Profile Plate and Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240175Tigon Medical Fractures, Instability, and Reconstruction (FIRE)Tigon Medical20240—
+1K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+1K193639APTUS® Foot 2.8-3.5 SystemMedartis AG20209—
+1K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation20174—
+1K151456Small Bone Nail ImplantVilex IN Tennessee, Inc.20150—
+1K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151—
+1K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+1K130510Arthrex Compression PlatesArthrex, Inc.20138—
+1K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+1K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+1K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc.20115—
+1K111326Osteowedge Opening Wedge Bone Locking SystemGraham Medical Technologies, LLC20111—
+1K103705Low Profile ScrewsArthrex, Inc.2011219—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+2K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+2K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+2K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+2K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+2K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG20232—
+2K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+2K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+2K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+2K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+2K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+2K201235Arthrex MaxForce MTP Compression Plates and ScrewsArthrex, Inc.20200—
+2K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+2K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+2K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+2K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+2K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+2K172886Breakaway Screw SystemParagon 2820174—
+2K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+2K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+2K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+2K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+2K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+2K162179osteo-WEDGE II ® Open Wedge Bone Locking Plate SystemGraham Medical Technologies, LLC Dba Gramedica20170—
+2K143721PRCT2Fx Solutions20150—
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+2K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+2K143365Eminent Foot Plate SystemEminent Spine20151—
+2K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+2K143614Arthrex Low Profile ScrewsArthrex, Inc.201519—
+2K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+2K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+2K133662Smith & Nephew Cannulated Captured ScrewSmith & Nephew, Inc.20148—
+2K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+2K132911I.B.S Snap-Off Screw / Solafix Snap-Off ScrewIn2bones Sas20140—
+2K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga20142—
+2K132217Arthrex Compression FT ScrewsArthrex, Inc.201318—
+2K131186Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSynthes (USA) Products, LLC20138—
+2K131061Restore Bunion Correction SystemNextremity Solutions201315—
+2K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+2K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+2K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+2K112437Arthrex Fracture SystemArthrex, Inc.201191—
+2K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011135—
+3K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+3K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+3K254215Arthrex Beaming SystemArthrex, Inc.20261—
+3K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+3K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+3K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+3K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+3K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+3K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+3K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+3K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+3K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+3K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+3K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+3K230546SignexOsteonic Co., Ltd.20242—
+3K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+3K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+3K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+3K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+3K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+3K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+3K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+3K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+3K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+3K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+3K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+3K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+3K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+3K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+3K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+3K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—