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
+1K152527Integra DigiFuse Cannulated Intramedullary Fusion SystemAscension Orthopedics20151—
+1K151021OsteoMed Cannulated Screw SystemOsteomed Corp.201516—
+1K140283Osteomed Extremifuse SystemOsteomed20140—
+1K130412Osteomed Extremifuse SystemOsteomed20134—
+1K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+1K111536Metasurg Digifuse ImplantMetasurg201130—
+1K103705Low Profile ScrewsArthrex, Inc.2011219—
+1K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH200948—
+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—
+2K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+2K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+2K201235Arthrex MaxForce MTP Compression Plates and ScrewsArthrex, Inc.20200—
+2K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+2K182989AURORA™ Screw SystemMiRus, LLC20180—
+2K171690Trident Extremity Fixation SystemTrident Orthopedics20180—
+2K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+2K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+2K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+2K163303OsteoMed ExtremiFix Mid and Large Screw SystemOsteomed, LLC20173—
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K153338Tiger Cannulated Screw SystemTrilliant Surgical, Ltd.201674
+2K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+2K150211EzFuze Implant SystemVilex IN Tennessee, Inc.20150—
+2K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+2K143614Arthrex Low Profile ScrewsArthrex, Inc.201519—
+2K141937Trident Fusion ImplantVilex IN Tennessee, Inc.20141—
+2K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+2K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+2K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+2K133662Smith & Nephew Cannulated Captured ScrewSmith & Nephew, Inc.20148—
+2K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+2K132911I.B.S Snap-Off Screw / Solafix Snap-Off ScrewIn2bones Sas20140—
+2K133515Peek Fusion ImplantMtp Solutions, LLC20142—
+2K132217Arthrex Compression FT ScrewsArthrex, Inc.201318—
+2K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+2K131186Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSynthes (USA) Products, LLC20138—
+2K131061Restore Bunion Correction SystemNextremity Solutions201315—
+2K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+2K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+2K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+2K122959Hammer Toe ImplantTrilliant Surgical, Ltd.2012221
+2K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+2K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets20129—
+2K112437Arthrex Fracture SystemArthrex, Inc.201191—
+2K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+2K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+2K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011135—
+2K102528N-Force Fixation SystemInnovision, Inc.20115—
+2K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH20118—
+2K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+2K101254Newfix Screw, Wire and Pin Fixarion SystemTecnologia Y Diseno Industrial, S.A DE C.V20101—
+3K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+3K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+3K254215Arthrex Beaming SystemArthrex, Inc.20261—
+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—
+3K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+3K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+3K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+3K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+3K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+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—
+3K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+3K230744Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC20231—
+3K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+3K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+3K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+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—
+3K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+3K203595DynaFuse Fixation SystemMedShape, Inc.20225—
+3K211996Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc.20210—
+3K210159IntraLock SystemFusion Orthopedics, LLC20210—
+3K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+3K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+3K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+3K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+3K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+3K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+3K200226RetroFixRetrofix Screws, LLC20200—
+3K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+3K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+3K181898Two-Step Implant SystemTrilliant Surgical20180—
+3K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+3K180932Diamond Orthopedic Bone Fixation Screws and PinsDiamond Orthopedic, LLC20180—