# K020455: Tissuemend Soft Tissue Repair Matrix

- Pathway: 510(k) (Abbreviated)
- Applicant: Tei Biosciences, Inc.
- Decided: Apr 3, 2002 after 51 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: 3 generations back to K921895 (1992). 7 ancestors in all.
56 later devices descend from it; 5 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992556: Permacol, Tissue Science Laboratories, Plc (2000) Summary page 1.
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 1.

## Most influential descendants
- K031188: Orthomend (2003), 36 descendants of its own
- K051766: Orthomend (2005), 35 descendants of its own
- K060829: Cosmatrix (2006), 18 descendants of its own
- K071807: Orthomend Soft Tissue Matrix (2007), 17 descendants of its own
- K051405: Regensis Pericardial Patch (2005), 15 descendants of its own

## Indications for use
TissueMend™ 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 abdominal, inguinal, diaphragmatic, femoral, scrotal, umbilical, and incisional hernias; colon, rectal, urethral, and vaginal prolapse; muscle flap reinforcement; reconstruction of the pelvic floor; and procedures such as sacrocolposuspension and urethral sling.

Source page: https://510kreport.com/device/K020455
Methodology: https://510kreport.com/methodology