510(k) Report

Devices descending from K051219

151 later devices reach Pushlock through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K101448Opus Speedscrew SystemArthrocare Corp.2010101
+4K100457Opus Speedscrew SystemArthrocare Corp.201015—
+4K091870Tornier, Piton Fixation Implant SystemTornier20096—
+5K254229Arthrex Nano FiberTak Suture AnchorArthrex, Inc.20260—
+5K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+5K252022OSSIOfiber® Interference ScrewOSSIO, Ltd.20250—
+5K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+5K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+5K231113Arthrex FiberTak Suture AnchorArthrex, Inc.20235—
+5K230568FiberTak Suture AnchorArthrex, Inc.20236—
+5K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+5K221396Arthrex FiberTak Suture AnchorArthrex, Inc.20223—
+5K222161Arthrex Knotless FiberTak Biceps Suture AnchorArthrex, Inc.20220—
+5K201648Sterispine™ PSSafe Orthopaedics202011
+5K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+5K171582NEO Pedicle Screw System™Neo Medical SA20170—
+5K170528Sterispine™ PSSafe Orthopaedics20172—
+5K153313SpeedLock Knotless Fixation SystemArthroCare Corporation20150—
+5K151921Sterispine PSSafe Orthopaedics20153—
+5K151747Sterispine PSSafe Orthopaedics20153—
+5K150092STERISPINE PS Pedicle ScrewSafe Orthopaedics20154—
+5K141774Zoll X SeriesZOLL Medical Corporation20142—
+5K133484Zoll X SeriesZoll Medical Corp20141—
+5K140802Sterispine PSSafe Orthopaedics20144—
+5K140604Multifix S Knotless Fixation SystemArthroCare Corporation20142—
+5K130632Sterispine PS Pedicle ScrewSafe Orthopaedics20135—
+5K121299Sterispineps Pedicle Screw, Sterispineps RodSafe Orthopaedics20126—
+5K111716Knotless Suture Fixation SystemCore Essence Orthopaedics20110—
+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—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+6K250596Arthrex FiberTak Suture AnchorArthrex, Inc.20250—
+6K241235Arthrex TightRope IIArthrex, Inc.20243—
+6K232742Arthrex FiberTak Suture AnchorArthrex, Inc.20234—
+6K231330FiberTak® Suture AnchorArthrex, Inc.20235—
+6K230433Arthrex Knotless FiberTak Suture AnchorArthrex, Inc.20230—
+6K202375ZOLL Propaq MZOLL Medical Corporation20211—
+6K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+6K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.20152—
+6K151660MultiFIX S Knotless Fixation SystemArthroCare Corporation20151—
+6K142915ZOLL X SeriesZOLL Medical Corporation20140—
+6K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc.20140—
+6K132632Tornier Insite FT Suture Anchor with NeedlesTornier, Inc.20130—
+7K260405FiberTape ButtonArthrex, Inc.20260—
+7K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+7K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+7K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+7K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+7K153669MultiFIX S Ultra Knotless Fixation SystemArthocare Corporation20160—