510(k) Report

Devices descending from K954330

464 later devices reach Super Screw 3.5 MM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K102528N-Force Fixation SystemInnovision, Inc.20115—
+3K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH20118—
+3K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+3K101254Newfix Screw, Wire and Pin Fixarion SystemTecnologia Y Diseno Industrial, S.A DE C.V20101—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+4K254215Arthrex Beaming SystemArthrex, Inc.20261—
+4K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+4K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+4K252246Leforte MMF SystemJeil Medical Corporation20260—
+4K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+4K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+4K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+4K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+4K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+4K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho20241—
+4K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+4K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+4K230546SignexOsteonic Co., Ltd.20242—
+4K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+4K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+4K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+4K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+4K221342REDEMPTION Beaming SystemVilex, LLC20220—
+4K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+4K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+4K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+4K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+4K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+4K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+4K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+4K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+4K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+4K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+4K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+4K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+4K211996Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc.20210—
+4K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+4K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+4K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+4K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+4K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+4K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+4K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+4K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+4K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+4K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+4K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+4K200226RetroFixRetrofix Screws, LLC20200—
+4K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+4K190830TDM Screw SystemsTdm Co., Ltd.20191—
+4K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+4K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+4K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+4K190586Monster® Screw SystemParagon 28, Inc.201921—
+4K182677DynaNail MiniMedShape, Inc.20195—
+4K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+4K181898Two-Step Implant SystemTrilliant Surgical20180—
+4K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+4K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+4K180932Diamond Orthopedic Bone Fixation Screws and PinsDiamond Orthopedic, LLC20180—
+4K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+4K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+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—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+4K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+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—
+4K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+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—
+4K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—