510(k) Report

Devices descending from K963172

722 later devices reach Synthes Sterile 4.5 MM Cannulated Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+5K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+5K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+5K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+5K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+5K241235Arthrex TightRope IIArthrex, Inc.20243—
+5K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+5K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+5K240715Idys® C ZP 3DTiClariance20240—
+5K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+5K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+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—
+5K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+5K220966SinefixBAAT Medical Products B.V.20231—
+5K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+5K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+5K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+5K221395Footmotion Plating SystemNewclip Technics20220—
+5K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+5K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+5K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+5K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+5K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+5K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K213214Xpert WristNewclip Technics20210—
+5K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+5K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+5K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+5K212562Idys-C ZP 3DTiClariance, SA20211—
+5K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+5K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+5K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+5K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+5K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+5K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+5K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+5K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+5K202307Activ FuseNewclip Technics20200—
+5K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+5K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+5K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+5K191972ARIX Wrist SystemJeil Medical Corporation20190—
+5K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+5K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+5K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+5K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+5K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+5K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+5K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+5K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+5K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+5K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+5K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+5K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+5K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+5K162198GFS UltimateParcus Medical, LLC20168—
+5K152622Alta ACDF SystemBiomet Spine20160—
+5K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+5K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+5K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+5K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+5K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+5K142653G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd.20140—
+5K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+5K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+5K140328CMC Mini TightropeArthrex, Inc.20146—
+5K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC201416—
+5K132502Variax 2 SystemStryker Trauma AG201321—
+5K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+6K252246Leforte MMF SystemJeil Medical Corporation20260—
+6K242303MOD-COrthomod, LLC20260—
+6K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+6K254176SinefixBAAT Medical Products B.V.20260—
+6K260405FiberTape ButtonArthrex, Inc.20260—
+6K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+6K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K251933SnugFit ASA ExtensionMedacta International S.A.20250—