# K971332: Ams Mainstay Urologic Bone Anchor

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Systems, Inc.
- Decided: Jul 9, 1997 after 90 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 K953531 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953531: Howmedica Mainstay Anchor, Howmedica Corp. (1995) Summary page 1.

## Indications for use
The AMS Mainstay™ Urologic Bone Anchor is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency

Source page: https://510kreport.com/device/K971332
Methodology: https://510kreport.com/methodology