# K964953: IN-Tac Bone Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: Influence, Inc.
- Decided: Feb 13, 1997 after 70 days
- Product code: HXJ (Staple Driver)
- Device class: 1
- Regulation: 21 CFR 888.4540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K920213 (1992). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962372: Urotac Bone Anchor Inserter, Influence, Inc. (1996) Summary page 1.

## Most influential descendants
- K990160: Microtac-Bone Anchor System (1999), 1 descendant of its own
- K992277: Stapletac Bone Anchor System (1999), 0 descendants of its own

## Indications for use
The In-Tac Bone Anchor System is indicated for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K964953
Methodology: https://510kreport.com/methodology