510(k) Report

Devices descending from K003227

526 later devices reach Bio-Absorbable Corkscrew Model AR-1920B through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+5K203794HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMedos International SARL20210—
+5K202777VeriFixx™ Small Bone ImplantArmis Biopharma, Inc.20200—
+5K202307Activ FuseNewclip Technics20200—
+5K202355Stryker Omega PEEK Knotless Anchor SystemStryker20200—
+5K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+5K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+5K201850Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20203—
+5K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+5K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC20203—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K191227Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20201—
+5K193606Y-Knot OneStep AnchorConmed Corporation20200—
+5K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+5K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+5K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+5K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+5K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+5K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+5K191424Interphalangeal Joint Fusion Device RangeNeosteo20190—
+5K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+5K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+5K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+5K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+5K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+5K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K183055Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC20194—
+5K183331Parcus GFS BTBParcus Medical, LLC20193—
+5K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+5K182621CrossFT Knotless Deep Thread Suture Anchor with Disposable DriverConmed Corporation20190—
+5K182736OIC Suture Anchor SystemThe Orthopaedic Implant Company20180—
+5K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+5K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+5K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—
+5K173556Injection ScrewBiedermann Medtech, Inc.20180—
+5K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+5K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+5K173859HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20184—
+5K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker20185—
+5K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+5K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+5K171725CuffLink Implant SystemConmed Corporation20170—
+5K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20171—
+5K171465Stryker Self-Punching ICONIXStryker20171—
+5K170098ICONIX TT All Suture AnchorStryker20173—
+5K161449HammerTech Fixation SystemFusion Orthopedics, LLC20165—
+5K160655OrthoButton CLRiverpoint Medical20169—
+5K160500Elite SPK, Compasso, Elite SPK KitNcs Lab Srl20160—
+5K152711Parcus GFS NakedParcus Medical, LLC20154—
+5K152710HammerFiX DeviceExtremity Medical, LLC20151—
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+5K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+5K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201516—
+5K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+5K142230Apollo Suture Anchor System and Titan ScrewsValeris Medical201451
+5K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.20140—
+5K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+5K140769Variax 2 SystemStryker Trauma AG201419—
+5K140328CMC Mini TightropeArthrex, Inc.20146—
+5K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi SuturesConmed Corporation201412—
+5K112417VariousDepuy Mitek, A Johnson & Johnson Company20120—
+5K113299Rog Suture AnchorRog Sports Medicine, Inc.20112—
+5K112991Modified Rog Suture AnchorRog Sports Medicine, Inc.20111—
+5K111000Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC20114—
+5K1107815.5 / 6.5MM Spartan Peek Surture Implant with #2 Magnumwire / with Needles, Extraction…Arthrocare Corp.20110—
+5K1101645.5MM Spartan Peek Suture Implant W/ #2 Magnum Wire, Punch Tap, Extraction ToolArthrocare Corp.20111—
+5K091094Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC20097—
+6K254280F.A.S.T ScrewSteps Ortho20260—
+6K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC20260—
+6K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+6K262677Iconix Knotless TRiverpoint Medical20260—
+6K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+6K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K254215Arthrex Beaming SystemArthrex, Inc.20261—
+6K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+6K252246Leforte MMF SystemJeil Medical Corporation20260—
+6K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+6K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+6K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251—
+6K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+6K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+6K251296The Acumed Wrist Fixation SystemAcumed, LLC202501
+6K251530CONMED Argo Knotless® AnchorConmed Corporation20250—
+6K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+6K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+6K250596Arthrex FiberTak Suture AnchorArthrex, Inc.20250—
+6K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+6K241234OTS 25-L (100-5)Ots Medical, Ltd.20251—
+6K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+6K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+6K243323Iconix Knotless AnchorRiverpoint Medical20240—
+6K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—