# K243302: 3DMatrix DynaFlex (DynaFlex)

- Pathway: 510(k) (Traditional)
- Applicant: Printbio, Inc.
- Decided: May 21, 2025 after 215 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: 10 generations back to K921895 (1992). 54 ancestors in all.
No later device cites it as a predicate yet.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232602: 3DMatrix Surgical Mesh, Printbio, Inc. (2024) Summary page 5.

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

Source page: https://510kreport.com/device/K243302
Methodology: https://510kreport.com/methodology