510(k) Report

Devices descending from K000080

916 later devices reach Asnis Iii Cannulated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+5K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+5K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+5K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+5K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+5K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+5K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+5K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+5K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+5K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+5K141992Variax 2 SystemStryker Trauma AG201422—
+5K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+5K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+5K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+5K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+5K130092Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.201385—
+5K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+6K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K261191Alians Elbow SNewclip Technics20260—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+6K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+6K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+6K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+6K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+6K252961Fusion FibFix NailFusion Orthopedics USA, LLC20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+6K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+6K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+6K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+6K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+6K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+6K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+6K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+6K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+6K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+6K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+6K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K241539Activmotion SNewclip Technics20240—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K240715Idys® C ZP 3DTiClariance20240—
+6K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+6K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+6K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+6K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+6K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+6K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K230204ALPHALOK Plating SystemVilex, LLC20230—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+6K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+6K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+6K221558ALPHALOK Plating SystemVilex, LLC20222—
+6K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+6K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+6K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+6K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+6K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+6K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+6K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+6K212562Idys-C ZP 3DTiClariance, SA20211—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+6K203381Dynanail Mini HybridMedShape, Inc.202141
+6K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+6K202810AutoStrut G2Orthospin, Ltd.20213—
+6K201664FIREBIRD SI Fusion SystemOrthofix, Inc.202026—
+6K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+6K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+6K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc.20208—
+6K200226RetroFixRetrofix Screws, LLC20200—
+6K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+6K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+6K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+6K193366T2 ICFStryker GmbH20201—
+6K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—