# K061578: SSP Vertebral Body Replacement

- Pathway: 510(k) (Traditional)
- Applicant: Specialty Spine Products, LLC
- Decided: Dec 26, 2006 after 202 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
Longest line of descent: 3 generations back to K003275 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003275: Synthes Synmesh Spacer System, Synthes (Usa) (2001) Summary page 2.
- K030744: Blackstone Surgical Titanium Mesh, Blackstone Medical, Inc. (2003) Summary page 2.
- K032700: Blackstone Surgical Titanium Mesh System Angled End Rings, Blackstone Medical, Inc. (2003) Summary page 2.

## Indications for use
The SSP Vertebral Body Replacement is a complete or partial vertebral body replacement device intended for use in the thoracolumbar spine (Ti - L5) to provide anterior and middle column support after removal or resection of a damaged, collapsed, or unstable vertebral body due to tumor or trauma (e.g., fracture). The SSP Vertebral Body Replacement is intended to be used with the Specialty Spine Products Pedicle Screw System or with supplemental internal fixation systems cleared for the conditions listed above, and is intended to be used with bone graft. It is designed to provide anterior column support even in the absence of fusion for a prolonged period.

Source page: https://510kreport.com/device/K061578
Methodology: https://510kreport.com/methodology