# K040096: Spinal Concepts, Inc. Tandem Spinous Process Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Concepts, Inc.
- Decided: Jul 1, 2004 after 163 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- 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) Meurig-Williams Plate: named in the summary without a submission number

## Indications for use
The Spinous Process Plate is intended for fixation to adjacent spinous processes (LI-L5) as an adjunct to anterior interbody fusion and bone graft. The indications for the spinous process plate include spinal trauma, spondylolisthesis and degenerative disc disease. The spinous process plate should only be used in the presence of a vertebral body replacement device such as the Spinal Concepts, Inc. InFix® System.

Source page: https://510kreport.com/device/K040096
Methodology: https://510kreport.com/methodology