510(k) Report

Devices descending from K100457

15 later devices reach Opus Speedscrew System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111716Knotless Suture Fixation SystemCore Essence Orthopaedics20110—
+1K102262Arthocare Spartan Peek Suture Implant System; Punch Tap ; Extraction ToolArthrocare Corp.20102—
+1K101448Opus Speedscrew SystemArthrocare Corp.2010101
+2K131182Multifix S Knotless Fixation DeviceArthocare Corporation20139—
+2K1107815.5 / 6.5MM Spartan Peek Surture Implant with #2 Magnumwire / with Needles, Extraction…Arthrocare Corp.20110—
+2K1101645.5MM Spartan Peek Suture Implant W/ #2 Magnum Wire, Punch Tap, Extraction ToolArthrocare Corp.20111—
+3K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+3K1325905.5MM Multifix S Knotless Fixation Device, 6.5MM Multifix S Knotless Fixation Device…ArthroCare Corporation20133—
+4K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+4K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+4K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+4K140604Multifix S Knotless Fixation SystemArthroCare Corporation20142—
+5K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+5K151660MultiFIX S Knotless Fixation SystemArthroCare Corporation20151—
+6K153669MultiFIX S Ultra Knotless Fixation SystemArthocare Corporation20160—