# K003970: Contour Labral Nail, Model 533520A

- Pathway: 510(k) (Special)
- Applicant: Bionx Implants, Inc.
- Decided: Jan 12, 2001 after 21 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: 3 generations back to K911837 (1991). 4 ancestors in all.
79 later devices descend from it; 2 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.
- K992567: Anatomical Bankart Tack, Model 523520A, Bionx Implants, Ltd. (1999) Summary page 2.

## Most influential descendants
- 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
- K091549: Conmed Linvatec Soft Tissue to Bone System (2009), 56 descendants of its own

## Indications for use
The Bionx Contour Labral Nail™ 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 Contour Labral Nail™ 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/K003970
Methodology: https://510kreport.com/methodology