# K963932: Preloaded Soft Tissue Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Jun 20, 1997 after 262 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K892126 (1989). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892126: Mitek Anchor, Mitek Surgical Products, Inc. (1989) Summary page 3.
- K926384: Statak & Mini-Statak Soft Tissue Attachment Device, Zimmer, Inc. (1993) Summary page 3.

## Most influential descendants
- K990770: Biorc Anchor (1999), 0 descendants of its own

## Indications for use
The Linvatec Preloaded Soft Tissue Anchor is indicated for bladder neck suspension for femine urinary incontinence due to urethral hypermobility.

Source page: https://510kreport.com/device/K963932
Methodology: https://510kreport.com/methodology