# K232602: 3DMatrix Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Printbio, Inc.
- Decided: May 23, 2024 after 269 days
- Product code: OXF (Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery)
- 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: 9 generations back to K921895 (1992). 53 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163217: GORE BIO-A Tissue Reinforcement, W. L. Gore & Associates, Inc. (2017) Summary page 4.

## Most influential descendants
- K243302: 3DMatrix DynaFlex (DynaFlex) (2025), 0 descendants of its own

## Indications for use
3DMatrix is indicated for the reinforcement of soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery. Examples of applications where 3DMatrix may be used include: - Suture line reinforcement including for hernia repair - Muscle flap reinforcement - General tissue reconstructions

Source page: https://510kreport.com/device/K232602
Methodology: https://510kreport.com/methodology