# K090022: Paradis Vaso Shield

- Pathway: 510(k) (Traditional)
- Applicant: Spinemedica, LLC
- Decided: Apr 20, 2009 after 105 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
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K103558: Synthes Scout Vessel Guard (2011), 1 descendant of its own
- K100905: Hydrofix Surgical Sheet (2010), 1 descendant of its own
- K111048: Synthes Scout Tack Fixation (2012), 0 descendants of its own
- K111137: Hydrofix Vaso Shield (2011), 0 descendants of its own
- K101805: Hydrofix Vaso Shield (2011), 0 descendants of its own

## Indications for use
The Paradis Vaso ShieldTM is indicated for use as a cover for vessels following anterior vertebral surgery.

Source page: https://510kreport.com/device/K090022
Methodology: https://510kreport.com/methodology