# K042600: Stansion Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Spineworks, LLC
- Decided: Feb 18, 2005 after 148 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- 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
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) Interpore Cross International GEO Structure: named in the summary without a submission number
- (no number) Depuy AcroMed, Inc. Stackable Cage System: named in the summary without a submission number
- (no number) Osteotech, Inc. VBR: named in the summary without a submission number
- (no number) Orthovita Endoskeleton TA VBR: named in the summary without a submission number

## Indications for use
The Stansion MatrixTM ("Stansion Matrix") is indicated for use in the thoracolumbar spine (i.e., Ti to L5) to replace a portion of a diseased vertebral body that is resected or excised for the treatment of tumors, where the defect is contained within a single vertebral body, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The device is also indicated for treating fractures of the thoracic and lumbar spine. The Stansion Matrix is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The device is intended for use with supplemental rigid posterior pedicle screw fixation.

Source page: https://510kreport.com/device/K042600
Methodology: https://510kreport.com/methodology