# K970292: IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Influence, Inc.
- Decided: Apr 23, 1997 after 89 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K920213 (1992). 5 ancestors in all.
40 later devices descend from it; 4 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962372: Urotac Bone Anchor Inserter, Influence, Inc. (1996) Summary page 1.
- K932925: Bone Anchor for Soft Tissue Attachment, Vesitec Medical, Inc. (1994) Summary page 1.
- K920213: Mitek Anchor, Mitek Anchor II, Mitek Surgical Products, Inc. (1992) Summary page 1.
- K953264: Questus Polyester Suture Soft Tissue Anchor System, Wrightmedicaltechnologyinc (1995) Summary page 1.
- K963200: Questus Polyester Suture Soft Tissue Anchor System, Wrightmedicaltechnologyinc (1996) Summary page 1.

## Most influential descendants
- 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
- K972622: Straight-in Bone Screw Fixation System (1997), 14 descendants of its own

## Recalls of this device
- Jan 28, 2008 · Not classified · Z-1235-2008: Missing part: The units in two lots of In-Fast Ultra Transvaginal Bladder Neck Support System may contain only one bone screw, but should contain two as indicated on the labeling. Two screws are requi

## Indications for use
The In-Fast Bone Screw System is indicated for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K970292
Methodology: https://510kreport.com/methodology