# K960516: Fastak Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Apr 18, 1996 after 73 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
197 later devices descend from it; 4 cite it directly.
0 of 198 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Mitek GII Anchor: named in the summary without a submission number

## Most influential descendants
- K972783: Biofix Biodegradable Threaded Suture Anchor (1998), 166 descendants of its own
- K982139: Biosorbfx 1.5/2.0 Bioabsorbable Fixation System (1998), 86 descendants of its own
- K993061: Stryker Leibinger Resorbable Fixation System (1999), 79 descendants of its own
- K020056: Duet Suture Anchor (2002), 78 descendants of its own
- K030388: Impact Suture Anchor. Model 433510 (2003), 77 descendants of its own

## Indications for use
The FASTak Suture Anchor is intended for fixation of suture to bone. This product is intended for use in repairing rotator cutf tears and Bankart lesions.

Source page: https://510kreport.com/device/K960516
Methodology: https://510kreport.com/methodology