# K050610: Salute Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Davol Inc., Sub. C. R. Bard, Inc.
- Decided: May 25, 2005 after 76 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Salute Stapler and Staples: named in the summary without a submission number

## Recalls of this device
- Jul 16, 2007 · Not classified · Z-1267-2007: Malformed constructs (straight shots) may form causing injury to user/patient
- Jul 16, 2007 · Not classified · Z-1270-2007: Malformed constructs (straight shots) may form causing injury to user/patient
- Jul 16, 2007 · Not classified · Z-1272-2007: Malformed constructs (straight shots) may form causing injury to user/patient
- Jul 16, 2007 · Not classified · Z-1268-2007: Malformed constructs (straight shots) may form causing injury to user/patient
- Jul 16, 2007 · Not classified · Z-1266-2007: Malformed constructs (straight shots) may form causing injury to user/patient
- Jul 16, 2007 · Not classified · Z-1269-2007: Malformed constructs (straight shots) may form causing injury to user/patient
- Dec 27, 2006 · Not classified · Z-0374-2007: Inadequate directions for use in the Salute System. Labeling -Revised to provide updated instructions for use and proper servicing
- Dec 27, 2006 · Not classified · Z-0375-2007: Inadequate directions for use in the Salute System. Labeling -Revised to provide updated instructions for use and proper servicing

## Indications for use
The Salute® Fixation System is indicated for use in a variety of laparoscopic/endoscopic or open surgical procedures for fixation of prosthetic material and approximation of tissue.

Source page: https://510kreport.com/device/K050610
Methodology: https://510kreport.com/methodology