510(k) Report

Devices descending from K962823

836 later devices reach Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+4K172596Large Screws RangeNewclip Technics20174—
+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—
+4K170012Foot and Hand MotionNewclip Technics20170—
+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—
+4K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+4K160174I.B.S. 2.0 Osteosynthesis screwIn2bones Sas201617—
+4K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+4K153065The Hammertoe Correction SystemLife Spine, Inc.20162—
+4K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+4K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+4K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…Merete Medical GmbH20160—
+4K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+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—
+4K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+4K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+4K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+4K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+4K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+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—
+4K130298Biopro Kwick-Wire Universal Screw SystemBiopro, Inc.20132—
+4K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+4K091577Extremity Medical Midfoot Screw System, Charcx, Intramedullary Screw SystemExtremity Medical, LLC20094—
+4K060071Nexa Compression ScrewNexa Orthopedics, Inc.2006251—
+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—
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K261511Xpert AnkleNewclip Technics20260—
+5K261191Alians Elbow SNewclip Technics20260—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+5K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+5K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+5K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+5K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+5K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+5K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+5K254182AsterOsteonic Co., Ltd.20260—
+5K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+5K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+5K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+5K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+5K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+5K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+5K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+5K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+5K241539Activmotion SNewclip Technics20240—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+5K233919VariAx 2 Distal Radius SystemStryker GmbH20242—