# K100313: Hydrofix Surgical Sheet

- Pathway: 510(k) (Traditional)
- Applicant: Mimedx Group, Inc.
- Decided: Jun 14, 2011 after 495 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- 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: 13 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)
- K072190: Ortho-Wrap Bioresorbable Sheet, Mast Biosurgery (2008) Summary page 2.
- K090778: Mta Protective Sheet, Xylos Corporation (2009) Summary page 2.

## Indications for use
The MiMedx HydroFix TM Surgical Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The surgical sheet minimizes tissue attachment to the device in case of direct contact with the tissues.

Source page: https://510kreport.com/device/K100313
Methodology: https://510kreport.com/methodology