# K020446: Modification to Straight-in Bone Screw Fixation System

- Pathway: 510(k) (Special)
- Applicant: American Medical Systems, Inc.
- Decided: Mar 13, 2002 after 30 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972622: Straight-in Bone Screw Fixation System, Influence, Inc. (1997) Summary page 1.

## Indications for use
The Straight-In Bone Screw System is intended for soft tissue fixation to bones in the pelvic region (e.g., pubic, sacral, etc.) by means of bone screws threaded with suture. It is indicated for use during open or laparoscopic surgical procedures where soft tissue fixation to bones in the pelvic region is needed ‘(e.g., bladder neck suspension and urethral sling procedures for female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency).

Source page: https://510kreport.com/device/K020446
Methodology: https://510kreport.com/methodology