# K011910: IN-Fast Bone Screw System

- Pathway: 510(k) (Special)
- Applicant: American Medical Systems, Inc.
- Decided: Jul 13, 2001 after 24 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: 3 generations back to K920213 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970292: IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw, Influence, Inc. (1997) Summary page 1.

## Indications for use
The In-Fast Bone Screw System is intended for soft tissue fixation to the pubic bone by means of bone screws with attached suture. The In-Fast System is indicated for cystourethropexy and 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/K011910
Methodology: https://510kreport.com/methodology