# K932925: Bone Anchor for Soft Tissue Attachment

- Pathway: 510(k) (Traditional)
- Applicant: Vesitec Medical, Inc.
- Decided: Apr 26, 1994 after 315 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
129 later devices descend from it; 5 cite it directly.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K963369: Bio-Anchor (1997), 81 descendants of its own
- K983186: Bio-Anchor, Pre-Loaded Bioabsorbable Suture Anchor (1998), 80 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

## Recalls of this device
- Jun 2, 2006 · Not classified · Z-1309-06: The packages are labeled sterile, but the product was not sterilized.
- Jun 2, 2006 · Not classified · Z-1308-06: The packages are labeled sterile, but the product was not sterilized.

Source page: https://510kreport.com/device/K932925
Methodology: https://510kreport.com/methodology