# K162965: SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction

- Pathway: 510(k) (Traditional)
- Applicant: Tei Biosciences, Inc.
- Decided: Feb 16, 2017 after 115 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- 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: 10 generations back to K921895 (1992). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083898: Surgimend, Tei Biosciences, Inc. (2009) Summary page 4.

## Recalls of this device
- May 23, 2023 · Class II · Z-2073-2023: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

## Indications for use
SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: • Plastic and reconstructive surgery • Muscle flap reinforcement • Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias.

Source page: https://510kreport.com/device/K162965
Methodology: https://510kreport.com/methodology