# K103558: Synthes Scout Vessel Guard

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine
- Decided: Feb 18, 2011 after 78 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: 4 generations back to K811841 (1981). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061727: Gore Preclude Vessel Guard, W. L. Gore & Associates, Inc. (2006) Summary page 1.
- K090022: Paradis Vaso Shield, Spinemedica, LLC (2009) Summary page 1.
- K093551: Paradis Vaso Shield, Spinemedica, LLC (2009) Summary page 1.
- K082782: Replication Medical Vessel Guard, Replication Medical, Inc. (2009) Summary page 1.

## Most influential descendants
- K111048: Synthes Scout Tack Fixation (2012), 0 descendants of its own

## Indications for use
The Scout Vessel Guard is indicated as a cover for vessels during anterior vertebral surgery.

Source page: https://510kreport.com/device/K103558
Methodology: https://510kreport.com/methodology