# K060984: Xenform Soft Tissue Repair Matrix

- Pathway: 510(k) (Special)
- Applicant: Tei Biosciences, Inc.
- Decided: May 17, 2006 after 37 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K921895 (1992). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051190: Xenform Soft Tissue Repair Matrix, Tei Biosciences, Inc. (2005) Summary page 2.

## Indications for use
Xenform Soft Tissue Repair Matrix is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of colon, rectal, urethral, and vaginal prolapse; reconstruction of the pelvic floor; and procedures such as sacrocolposuspension and urethral sling.

Source page: https://510kreport.com/device/K060984
Methodology: https://510kreport.com/methodology