# K982155: Short Straight-in Bone Screw Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Influence, Inc.
- Decided: Aug 31, 1998 after 74 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- 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.
12 later devices descend from it; 2 cite it directly.
0 of 20 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.

## Most influential descendants
- K053371: Ams Male Transobturator Sling System (2006), 10 descendants of its own
- K082640: Virtue Ventral Urethral Elevation Sling System (2008), 5 descendants of its own
- K091152: Virtue Ventral Urethral Elevation Sling System, Model 50020 (2009), 4 descendants of its own
- K101297: Virtue Ventral Urethral Elevation Sling System Model 50020 (2010), 3 descendants of its own
- K182169: AdVance XP Male Sling (2018), 2 descendants of its own

## Indications for use
The Short Shaft Straight-In Bone Screw Fixation 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 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, sling procedure for male stress urinary incontinence resulting from prostatectomy).

Source page: https://510kreport.com/device/K982155
Methodology: https://510kreport.com/methodology