# K973849: Bioabsorbable Bankart Tack

- Pathway: 510(k) (Traditional)
- Applicant: Hogan & Hartson
- Decided: Jan 6, 1998 after 90 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: 1 generation back to K911837 (1991). 2 ancestors in all.
81 later devices descend from it; 4 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)
- K911837: Suretac Polyglyconate Absorbable Fixation Device, Acufex Microsurgical, Inc. (1991) Summary page 1.
- K964521: Depuy Dupont Phantom Suture Anchor, Depuy, Inc. (1997) Summary page 1.

## Most influential descendants
- K992567: Anatomical Bankart Tack, Model 523520A (1999), 80 descendants of its own
- 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

## Indications for use
The Bionx 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 Eion.x 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 ligament in patients with primary or recurrent anterior dislocation or subluxation of the shoulder (i.e., Bankart lesions).

Source page: https://510kreport.com/device/K973849
Methodology: https://510kreport.com/methodology