510(k) Report

Devices descending from K000506

186 later devices reach Bio-Fastak Suture Anchor, Model AR-1324B through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+5K260317Artelon Convenience KitsInternational Life Sciences20260—
+5K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+5K253538TeKBrace Knotless AnchorTheramicro20260—
+5K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251—
+5K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc.20250—
+5K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+5K250596Arthrex FiberTak Suture AnchorArthrex, Inc.20250—
+5K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd.20250—
+5K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+5K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek20241—
+5K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+5K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+5K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+5K231278Knotless Suture AnchorRiverpoint Medical, LLC202331
+5K220464Tigon Medical Gryphon Anchor LineTigon Medical20231—
+5K230433Arthrex Knotless FiberTak Suture AnchorArthrex, Inc.20230—
+5K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+5K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited20220—
+5K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+5K211322Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20210—
+5K210122Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)Osteonic Co., Ltd.20210—
+5K203268Arthrex FiberTak Suture AnchorArthrex, Inc.202016—
+5K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+5K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+5K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker20185—
+5K172491ICONN Square 2.5MM Suture AnchorIconn Orthopedics, LLC20170—
+5K172921Stryker Self-Punching ICONIXStryker20170—
+5K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL20162—
+5K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+5K1325905.5MM Multifix S Knotless Fixation Device, 6.5MM Multifix S Knotless Fixation Device…ArthroCare Corporation20133—
+5K130196Speedlock Knotless Fixation Device, 3MM Drill, 3MM+ Drill, Pathfinder Obturator & Sharp…Arthrocare Corp.20131—
+5K123240Speedlock Hip Knotless Fixation ImplantArthroCare Corporation20130—
+5K121865Zoll Rescuenet 12-LeadZOLL Medical Corporation20120—
+5K112453Sterispineps Pedicle ScrewSafe Orthopaedics201110—
+5K111296Zoll RescuenetlinkZoll Medical Corporation, World Wide Headquarters20115—
+5K111399Speedfix Suture Implant, 3.0MM Drill, Pathfinder Obturator, Sharp Tipped Obtrurator, Low…Arthrocare Corp.20110—
+5K102262Arthocare Spartan Peek Suture Implant System; Punch Tap ; Extraction ToolArthrocare Corp.20102—
+5K101448Opus Speedscrew SystemArthrocare Corp.2010101
+5K100457Opus Speedscrew SystemArthrocare Corp.201015—
+5K091870Tornier, Piton Fixation Implant SystemTornier20096—
+6K262677Iconix Knotless TRiverpoint Medical20260—
+6K254229Arthrex Nano FiberTak Suture AnchorArthrex, Inc.20260—
+6K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+6K252022OSSIOfiber® Interference ScrewOSSIO, Ltd.20250—
+6K243323Iconix Knotless AnchorRiverpoint Medical20240—
+6K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+6K240213Iconix Knotless AnchorRiverpoint Medical20240—
+6K231078All-Suture AnchorRiverpoint Medical, LLC20233—
+6K231113Arthrex FiberTak Suture AnchorArthrex, Inc.20235—
+6K230568FiberTak Suture AnchorArthrex, Inc.20236—
+6K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+6K222161Arthrex Knotless FiberTak Biceps Suture AnchorArthrex, Inc.20220—
+6K201648Sterispine™ PSSafe Orthopaedics202011
+6K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+6K171582NEO Pedicle Screw System™Neo Medical SA20170—
+6K170528Sterispine™ PSSafe Orthopaedics20172—
+6K153313SpeedLock Knotless Fixation SystemArthroCare Corporation20150—
+6K151921Sterispine PSSafe Orthopaedics20153—
+6K151747Sterispine PSSafe Orthopaedics20153—
+6K150092STERISPINE PS Pedicle ScrewSafe Orthopaedics20154—
+6K141774Zoll X SeriesZOLL Medical Corporation20142—
+6K133484Zoll X SeriesZoll Medical Corp20141—
+6K140802Sterispine PSSafe Orthopaedics20144—
+6K140604Multifix S Knotless Fixation SystemArthroCare Corporation20142—
+6K130632Sterispine PS Pedicle ScrewSafe Orthopaedics20135—
+6K121299Sterispineps Pedicle Screw, Sterispineps RodSafe Orthopaedics20126—
+6K111716Knotless Suture Fixation SystemCore Essence Orthopaedics20110—
+6K1107815.5 / 6.5MM Spartan Peek Surture Implant with #2 Magnumwire / with Needles, Extraction…Arthrocare Corp.20110—
+6K1101645.5MM Spartan Peek Suture Implant W/ #2 Magnum Wire, Punch Tap, Extraction ToolArthrocare Corp.20111—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K241577Iconix® AnchorRiverpoint Medical20240—
+7K241235Arthrex TightRope IIArthrex, Inc.20243—
+7K233468Iconix AnchorRiverpoint Medical20231—
+7K232742Arthrex FiberTak Suture AnchorArthrex, Inc.20234—
+7K231330FiberTak® Suture AnchorArthrex, Inc.20235—
+7K202375ZOLL Propaq MZOLL Medical Corporation20211—
+7K151660MultiFIX S Knotless Fixation SystemArthroCare Corporation20151—
+7K142915ZOLL X SeriesZOLL Medical Corporation20140—
+8K260405FiberTape ButtonArthrex, Inc.20260—
+8K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+8K252144Iconix Speed Anchor; Iconix Speed HA+ AnchorRiverpoint Medical20250—
+8K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+8K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+8K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+8K153669MultiFIX S Ultra Knotless Fixation SystemArthocare Corporation20160—