# K100905: Hydrofix Surgical Sheet

- Pathway: 510(k) (Special)
- Applicant: Mimedx Group, Inc.
- Decided: Jun 2, 2010 after 62 days
- Product code: OMR (Vessel Guard Or Cover)
- Device class: 2
- Regulation: 21 CFR 870.3470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K090022 (2009). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090022: Paradis Vaso Shield, Spinemedica, LLC (2009) Summary page 2.
- K093551: Paradis Vaso Shield, Spinemedica, LLC (2009) Summary page 2.

## Most influential descendants
- K101805: Hydrofix Vaso Shield (2011), 0 descendants of its own

## Indications for use
The MiMedx Group, Inc. HydroFixTM Vaso Shield is indicated as a cover for vessels during anterior vertebral surgery.

Source page: https://510kreport.com/device/K100905
Methodology: https://510kreport.com/methodology