# K152206: SurgiPure XD Reconstructive Tissue Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Tissue Regenix Group Plc
- Decided: Mar 8, 2016 after 215 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: 6 generations back to K921895 (1992). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070560: LRTM Surgical Mesh, Lifecell Corp. (2007) Summary page 4.

## Indications for use
SurgiPure® XD Reconstructive Tissue 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. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or buttressing material to obtain the desired surgical outcome. SurgiPure® XD Reconstructive Tissue Matrixis intended for single patient use only.

Source page: https://510kreport.com/device/K152206
Methodology: https://510kreport.com/methodology