510(k) Report

Devices descending from K012945

711 later devices reach Synthes 2.4 MM Cannulated Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+4K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+4K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+4K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+4K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+4K212552Correx SoftwareVilex, LLC20210—
+4K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+4K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+4K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC20212—
+4K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+4K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+4K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+4K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+4K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+4K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+4K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+4K202307Activ FuseNewclip Technics20200—
+4K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+4K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+4K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+4K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+4K200226RetroFixRetrofix Screws, LLC20200—
+4K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+4K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+4K192592Axis Plating SystemExtremity Medical, LLC20190—
+4K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+4K191636APTUS Foot SystemMedartis AG20190—
+4K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+4K191241AutoStrutOrthospin20194—
+4K182677DynaNail MiniMedShape, Inc.20195—
+4K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+4K182989AURORA™ Screw SystemMiRus, LLC20180—
+4K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+4K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+4K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+4K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+4K173883External Fixation SystemLife Spine, Inc.20180—
+4K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+4K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+4K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+4K173746Activmotion RangeNewclip Technics20181—
+4K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+4K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+4K172886Breakaway Screw SystemParagon 2820174—
+4K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+4K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+4K162171S4 Screw System™Subchondral Solutions20173—
+4K170547Arthrex Mesh Plate SystemArthrex, Inc.201715—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+4K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+4K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+4K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+4K170382Arthrex Compression ScrewsArthrex, Inc.20173—
+4K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+4K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+4K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie20170—
+4K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+4K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+4K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+4K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+4K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+4K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+4K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+4K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+4K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+4K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+4K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+4K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+4K150871ForeFoot STP SystemTornier, Inc.20150—
+4K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+4K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+4K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+4K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+4K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+4K143139Arthrex Fracture SystemArthrex, Inc.20151—
+4K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+4K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+4K141992Variax 2 SystemStryker Trauma AG201422—
+4K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+4K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+4K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+4K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+4K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+5K262975Arthrex Beaming SystemArthrex, Inc.20260—
+5K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—