510(k) Report

Devices descending from K011912

10 later devices reach Model 2000 Axyaloop Self-Tapping Bone Anchor, Model 2000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083268Tornier, Inc., Insite Suture AnchorsTornier, Inc.20097—
+1K052491Axya Model 6500 Axyaloop Self-Tapping Bone AnchorAxya Medical, Inc.2005921
+2K132632Tornier Insite FT Suture Anchor with NeedlesTornier, Inc.20130—
+2K122635Tornier Insite FT Biocomposite Suture AnchorTornier, Inc.20130—
+2K110773Tornier Insite FT Suture AnchorTornier, Inc.20115—
+2K102143Suspension Acromioclavicular (AC) Repair SystemSuspension Orthopaedic Solutions, LLC20100—
+3K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+3K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.20152—
+3K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc.20140—
+4K253538TeKBrace Knotless AnchorTheramicro20260—