# K963369: Bio-Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: May 22, 1997 after 268 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 K926384 (1993). 3 ancestors in all.
81 later devices descend from it; 3 cite it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926384: Statak & Mini-Statak Soft Tissue Attachment Device, Zimmer, Inc. (1993) Summary page 4.
- K950275: Resorbable Soft Tissue Attachment Device, Zimmer, Inc. (1995) Summary page 4.
- K932925: Bone Anchor for Soft Tissue Attachment, Vesitec Medical, Inc. (1994) Summary page 4.
- (no number) Mitek Surgical Products Gll Anchor: named in the summary without a submission number

## Most influential descendants
- 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
- K053561: Bio-Mini Revo Suture Anchor (2006), 75 descendants of its own

## Indications for use
The Linvatec Bio-Anchor is indicated for bladder neck suspension for female urinary incontinence due to urethral hypermobility.

Source page: https://510kreport.com/device/K963369
Methodology: https://510kreport.com/methodology