# K030667: Encore Anterior Spinal Staple System

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: May 28, 2003 after 86 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K980447 (1998). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974757: Kaneda Anterior Scoliosis System Kass, Acromed Corp. (1998) Summary page 1.
- K022605: Blackstone Spinal Fixation System Staple & Washer, Blackstone Medical, Inc. (2002) Summary page 1.

## Indications for use
The Encore Anterior Spinal Staple System is intended for anterior vertebral body fixation to the T3-L5 spine. This system is indicated to be used with an anterior spinal system that consists of screws that are between 6.0 and 6.5mm diameter manufactured out of Ti alloy.

Source page: https://510kreport.com/device/K030667
Methodology: https://510kreport.com/methodology