# K060829: Cosmatrix

- Pathway: 510(k) (Abbreviated)
- Applicant: Tei Biosciences, Inc.
- Decided: May 17, 2006 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: 4 generations back to K921895 (1992). 16 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020455: Tissuemend Soft Tissue Repair Matrix, Tei Biosciences, Inc. (2002) Summary page 1.
- K013625: Permacol, Tissue Science Laboratories, Plc (2002) Summary page 1.
- K034039: Sis Plastic Surgery Matrix, Cook Biotech, Inc. (2004) Summary page 1.

## Most influential descendants
- K071807: Orthomend Soft Tissue Matrix (2007), 17 descendants of its own
- K083898: Surgimend (2009), 9 descendants of its own
- K081272: Porcine Surgical Mesh; Dermal Matrix (2008), 6 descendants of its own
- K123128: Seri Surgical Scaffold (2013), 5 descendants of its own
- K140533: Galaflex Mesh (2014), 3 descendants of its own

## Indications for use
CosMatrix is intended for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.

Source page: https://510kreport.com/device/K060829
Methodology: https://510kreport.com/methodology