# K992277: Stapletac Bone Anchor System

- Pathway: 510(k) (Special)
- Applicant: Influence, Inc.
- Decided: Jul 30, 1999 after 23 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 4 generations back to K920213 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990160: Microtac-Bone Anchor System, Influence, Inc. (1999) Summary page 1.

## Indications for use
The StapleTac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors. It is indicated for vaginal sling procedures for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K992277
Methodology: https://510kreport.com/methodology