510(k) Report

Devices descending from K990987

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited20220—
+5K220757Argo Knotless SP AnchorConmed Corporation20226—
+5K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+5K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC20203—
+5K191227Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20201—
+5K193606Y-Knot OneStep AnchorConmed Corporation20200—
+5K191972ARIX Wrist SystemJeil Medical Corporation20190—
+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—
+5K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker20185—
+5K171725CuffLink Implant SystemConmed Corporation20170—
+5K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20171—
+5K171465Stryker Self-Punching ICONIXStryker20171—
+5K170098ICONIX TT All Suture AnchorStryker20173—
+5K160500Elite SPK, Compasso, Elite SPK KitNcs Lab Srl20160—
+5K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+5K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+5K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+5K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi SuturesConmed Corporation201412—
+5K132502Variax 2 SystemStryker Trauma AG201321—
+5K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+5K111000Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC20114—
+5K110773Tornier Insite FT Suture AnchorTornier, Inc.20115—
+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—
+6K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC20260—
+6K262677Iconix Knotless TRiverpoint Medical20260—
+6K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+6K260561Arthrex FiberTak Suture AnchorArthrex, 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—
+6K250596Arthrex FiberTak Suture AnchorArthrex, Inc.20250—
+6K241234OTS 25-L (100-5)Ots Medical, Ltd.20251—
+6K243323Iconix Knotless AnchorRiverpoint Medical20240—
+6K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+6K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+6K240090Argo Knotless GENESYS AnchorConmed Corporation20242—
+6K240213Iconix Knotless AnchorRiverpoint Medical20240—
+6K233429OTS 25 (100-1)Ots Medical, Ltd.20232—
+6K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+6K231078All-Suture AnchorRiverpoint Medical, LLC20233—
+6K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+6K230433Arthrex Knotless FiberTak Suture AnchorArthrex, Inc.20230—
+6K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+6K212739ActiFlipParcus Medical, LLC20210—
+6K211322Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20210—
+6K202663Suture WingOsteonic Co., Ltd.20211—
+6K192709Fixone All Suture AnchorAju Pharm Co., Ltd.20203—
+6K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+6K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+6K180763CuffLink Implant System BiocompositeConmed Corporation20180—
+6K173556Injection ScrewBiedermann Medtech, Inc.20180—
+6K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+6K172921Stryker Self-Punching ICONIXStryker20170—
+6K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+6K172186BioWick X Implant with DriverCayenne Medical, Inc.20174—
+6K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.20152—
+6K140769Variax 2 SystemStryker Trauma AG201419—
+6K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc.20140—
+6K132632Tornier Insite FT Suture Anchor with NeedlesTornier, Inc.20130—
+6K102326Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC20105—
+6K102162Parcus Peek CF Push-in Suture AnchorParcus Medical, LLC20100—
+7K253538TeKBrace Knotless AnchorTheramicro20260—
+7K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+7K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+7K244025Argo Knotless GENESYS AnchorConmed Corporation20251—
+7K241577Iconix® AnchorRiverpoint Medical20240—
+7K233659Suture WingOsteonic Co., Ltd.20230—
+7K233468Iconix AnchorRiverpoint Medical20231—
+7K222423Fixone All Suture AnchorAju Pharm Co., Ltd.202308
+7K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+7K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+7K183236Rotium Bioresorbable WickNanofiber Solutions, LLC20193—
+7K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+7K173135VariAx 2 SystemStryker GmbH201713—
+7K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+7K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+7K122805Parcus Draw Tight 1.8MM Single-Loaded Suture AnchorParcus Medical, LLC20131—
+8K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+8K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+8K252144Iconix Speed Anchor; Iconix Speed HA+ AnchorRiverpoint Medical20250—
+8K241912BiochargeNanofiber Solutions, LLC20240—
+8K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+8K231641Rotium Bioresorbable WickNanofiber Solutions, LLC20231—
+8K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+8K213109Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited20220—
+8K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+8K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+8K201414Rotium Bioresorbable WickNanofiber Solutions, LLC20202—
+8K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+8K180500VariAx 2 SystemStryker GmbH201812—
+8K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+9K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+9K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+9K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—