# K081418: Spinal Elements Buttress Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Elements, Inc.
- Decided: Jul 14, 2008 after 55 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: 2 generations back to K926453 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080302: Cayman Buttress Plate System, K2m, Inc. (2008) Summary page 1.
- K970048: Synthes (Usa)Titanium Locking Plate System (Tilps), Synthes (Usa) (1997) Summary page 1.

## Indications for use
The Spinal Elements Buttress Plate System is intended for anterior intravertebral body screw fixation/attachment to one vertebral body of the LI-SI spine, extending over the adjacent intervertebral space to stabilize and buttress bone grafts/intervertebral body fusion devices following reconstruction for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The system is intended to be used in skeletally mature patients in conjunction with traditional fixation and is not intended for load bearing applications.

Source page: https://510kreport.com/device/K081418
Methodology: https://510kreport.com/methodology