510(k) Report

Devices descending from K962011

738 later devices reach Synthes 7.0/7.3 MM Cannulated Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K182677DynaNail MiniMedShape, Inc.20195—
+4K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+4K182989AURORA™ Screw SystemMiRus, LLC20180—
+4K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+4K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+4K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+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—
+4K170056IRENE Cannulated Screw SystemTianjin Zhengtian Medical Instrument Co., Ltd.20170—
+4K170547Arthrex Mesh Plate SystemArthrex, Inc.201715—
+4K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+4K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+4K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+4K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+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—
+4K163440Stealth Staple SystemFirst Ray, LLC20173—
+4K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+4K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+4K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+4K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+4K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+4K151407RECON systemNormed Medizin-Technik GmbH20154—
+4K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+4K150871ForeFoot STP SystemTornier, Inc.20150—
+4K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+4K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+4K143139Arthrex Fracture SystemArthrex, Inc.20151—
+4K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+4K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+4K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+4K132893Edge Orthopaedics Bite Compression ScrewIcon Orthopaedic Concepts Dba Edge Orthopaedics20130—
+4K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+4K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+4K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+4K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+5K262975Arthrex Beaming SystemArthrex, Inc.20260—
+5K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+5K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+5K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+5K261511Xpert AnkleNewclip Technics20260—
+5K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+5K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+5K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+5K254182AsterOsteonic Co., Ltd.20260—
+5K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+5K243469SignexOsteonic Co., Ltd.20250—
+5K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+5K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+5K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+5K241895Cannulated PsiFGuardSpineguard20240—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+5K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+5K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+5K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+5K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+5K240715Idys® C ZP 3DTiClariance20240—
+5K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+5K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+5K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+5K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+5K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+5K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+5K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+5K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+5K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+5K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+5K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—