510(k) Report

Devices descending from K010783

484 later devices reach 2.0/2.4 Cannulated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+4K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+4K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+4K231860TDM Screw SystemTdm Co., Ltd.20240—
+4K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+4K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+4K230744Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC20231—
+4K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+4K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+4K221342REDEMPTION Beaming SystemVilex, LLC20220—
+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—
+4K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+4K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+4K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+4K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+4K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+4K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+4K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+4K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+4K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+4K203595DynaFuse Fixation SystemMedShape, Inc.20225—
+4K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+4K211996Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc.20210—
+4K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+4K210159IntraLock SystemFusion Orthopedics, LLC20210—
+4K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+4K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+4K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+4K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+4K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+4K203011Monster Screw SystemParagon 28, Inc.20206—
+4K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+4K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+4K200226RetroFixRetrofix Screws, LLC20200—
+4K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+4K193524SI-BONE iFuse Implant System®SI-BONE, Inc.202054—
+4K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+4K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+4K181898Two-Step Implant SystemTrilliant Surgical20180—
+4K181881Outlet Sacroiliac Joint Fusion SystemSij Surgical20184—
+4K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+4K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+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—
+4K172268iFuse Implant System- iFuse NavigationSI-BONE, Inc.201746—
+4K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+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—
+4K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc.201782—
+4K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+4K161755Integrity-SI TM Fusion SystemCoorstek Medical20162—
+4K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+4K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+4K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+4K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+4K152681iFuse Implant System (R)SI-BONE, Inc.201684—
+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—
+4K150017SpineFrontier SIJFuse Sacroiliac Joint Fusion Device SystemSpinefrontier, Inc.201514—
+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—
+4K140079Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc.201412—
+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—