# K171357: SurgiMend PRS Meshed, Revize-X

- Pathway: 510(k) (Special)
- Applicant: Integra Lifesciences Corporation (Owner of Tei Biosciences)
- Decided: Jun 7, 2017 after 29 days
- Product code: OXH (Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 2 (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 5.

## Recalls of this device
- May 23, 2023 · Class II · Z-2070-2023: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- May 23, 2023 · Class II · Z-2084-2023: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

## Indications for use
SurgiMend® Meshed is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend® Meshed is specifically indicated for plastic and reconstructive surgery.

Source page: https://510kreport.com/device/K171357
Methodology: https://510kreport.com/methodology