# K964521: Depuy Dupont Phantom Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Feb 6, 1997 after 86 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
No predicates in its family tree.
82 later devices descend from it; 3 cite it directly.
0 of 83 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) Zimmer Statak: named in the summary without a submission number
- (no number) Acufex Suretac Absorbable Tack: named in the summary without a submission number

## Most influential descendants
- K973849: Bioabsorbable Bankart Tack (1998), 81 descendants of its own
- 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

## Indications for use
The DePuy DuPont Phantom Suture Anchor is intended for use in the shoulder for soft tissue re-attachment and capsular repair, including rotator cuff repairs, Bankart lesion repairs and SLAP lesion repairs.

Source page: https://510kreport.com/device/K964521
Methodology: https://510kreport.com/methodology