510(k) Report

Devices descending from K021932

755 later devices reach Synthes 6.5 MM Cannulated Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+4K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+4K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+4K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+4K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+4K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+4K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K233256Robotic Integration InstrumentsDePuy Synthes20240—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K230546SignexOsteonic Co., Ltd.20242—
+4K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+4K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+4K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+4K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+4K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+4K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+4K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+4K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+4K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+4K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+4K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+4K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+4K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+4K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+4K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K222698CUVIS-spineCurexo, Inc.20220—
+4K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+4K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+4K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+4K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+4K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+4K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+4K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+4K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+4K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+4K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+4K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+4K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+4K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+4K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+4K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+4K203110iFuse Implant System - iFuse NavigationSI-BONE, Inc.20201—
+4K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+4K201664FIREBIRD SI Fusion SystemOrthofix, Inc.202026—
+4K200226RetroFixRetrofix Screws, LLC20200—
+4K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+4K192592Axis Plating SystemExtremity Medical, LLC20190—
+4K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+4K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+4K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+4K182983iFuse Implant System®SI-BONE, Inc.201871—
+4K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+4K173556Injection ScrewBiedermann Medtech, Inc.20180—
+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—
+4K170547Arthrex Mesh Plate SystemArthrex, Inc.201715—
+4K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+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—
+4K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie20170—
+4K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC20171—
+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—
+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—
+4K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+4K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+4K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+4K130092Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201385—
+4K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+5K262975Arthrex Beaming SystemArthrex, Inc.20260—
+5K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—