# K170530: Butrex Lumbar Buttress Plating System

- Pathway: 510(k) (Special)
- Applicant: X-Spine Systems, Inc.
- Decided: Mar 22, 2017 after 28 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)
- K072943: Butrex Buttress Plating System, X-Spine Systems, Inc. (2008) Summary page 5.
- K970048: Synthes (Usa)Titanium Locking Plate System (Tilps), Synthes (Usa) (1997) Summary page 5.

## Indications for use
The Butrex® Lumbar Buttress Plating System is intended for anterior intervertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent intervertebral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease (DDD). DDD is defined as follows: back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.

Source page: https://510kreport.com/device/K170530
Methodology: https://510kreport.com/methodology