510(k) Report

Devices descending from K221135

3 later devices reach X-Twist PEEK Suture Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+1K232513X-Twist Biocomposite Suture AnchorParcus Medical20230—
+2K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—