# K962372: Urotac Bone Anchor Inserter

- Pathway: 510(k) (Traditional)
- Applicant: Influence, Inc.
- Decided: Aug 19, 1996 after 61 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: 1 generation back to K920213 (1992). 2 ancestors in all.
44 later devices descend from it; 2 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920213: Mitek Anchor, Mitek Anchor II, Mitek Surgical Products, Inc. (1992) Summary page 1.
- K932925: Bone Anchor for Soft Tissue Attachment, Vesitec Medical, Inc. (1994) Summary page 1.

## Most influential descendants
- K970292: IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw (1997), 40 descendants of its own
- K972023: Sleep-in Bone Screw System (1997), 23 descendants of its own
- K981677: Repose Bone Screw System (1999), 16 descendants of its own
- K101060: Siesta Medical, Inc., Prelude Tongue Suspension System (2010), 15 descendants of its own
- K103179: Prelude II Tounge Suspension System (2010), 14 descendants of its own

## Indications for use
The UroTac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors threaded with suture. The UroTac Bone Anchor System is indicated for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility.

Source page: https://510kreport.com/device/K962372
Methodology: https://510kreport.com/methodology