# K111048: Synthes Scout Tack Fixation

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine
- Decided: Jun 14, 2012 after 426 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: 5 generations back to K811841 (1981). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103558: Synthes Scout Vessel Guard, Synthes Spine (2011) Summary page 1.
- K032534: Synthes Afs, Synthes Spine (2004) Summary page 1.
- K082782: Replication Medical Vessel Guard, Replication Medical, Inc. (2009) Summary page 1.
- K090470: Autosuture Protack; Tacker System; Absorbatack Fixation Devices, Covidien (2009) Summary page 1.

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

Source page: https://510kreport.com/device/K111048
Methodology: https://510kreport.com/methodology