# K972622: Straight-in Bone Screw Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Influence, Inc.
- Decided: Oct 9, 1997 after 87 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: 3 generations back to K920213 (1992). 6 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 21 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.
- K932925: Bone Anchor for Soft Tissue Attachment, Vesitec Medical, Inc. (1994) Summary page 1.

## Most influential descendants
- K982155: Short Straight-in Bone Screw Fixation System (1998), 12 descendants of its own
- 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

## Indications for use
The Straight-In Bone Screw Fixation System is intended for soft tissue fixation to the pubic bone by means of bone screws threaded with suture. It is indicated for use during open or laparoscopic surgical procedures where soft tissue fixation to the pubic bone 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/K972622
Methodology: https://510kreport.com/methodology