# K992567: Anatomical Bankart Tack, Model 523520A

- Pathway: 510(k) (Special)
- Applicant: Bionx Implants, Ltd.
- Decided: Aug 27, 1999 after 25 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K911837 (1991). 3 ancestors in all.
80 later devices descend from it; 3 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973849: Bioabsorbable Bankart Tack, Hogan & Hartson (1998) Summary page 2.

## Most influential descendants
- K003970: Contour Labral Nail, Model 533520A (2001), 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
- K042966: Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218, BXS4218H (2004), 76 descendants of its own
- K053561: Bio-Mini Revo Suture Anchor (2006), 75 descendants of its own

## Indications for use
The Bionx Anatomical Bankart Tack™ is intended for use to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Bionx Bankart Tack will be specifically indicated for use to provide internal fixation of soft tissue to bone for repair of anterior shoulder instability by reattachment of the glenoid labrum and/or inferior glenohumeral ligaments in patients with primary or recurrent anterior dislocation or subluxation of the shoulder (i.e. Bankart lesions).

Source page: https://510kreport.com/device/K992567
Methodology: https://510kreport.com/methodology