# K111137: Hydrofix Vaso Shield

- Pathway: 510(k) (Special)
- Applicant: Mimedx Group, Inc.
- Decided: May 20, 2011 after 28 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). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Cited in the summary but kept off the family tree
- K100905: Hydrofix Surgical Sheet, Mimedx Group, Inc. (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K101826: Hydrofix Vaso Shield, Model HVS-001-0610, Mimedx Group, Inc. (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K1001805: HydroFix Vaso Shield. Number could not be read

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

Source page: https://510kreport.com/device/K111137
Methodology: https://510kreport.com/methodology