# K032700: Blackstone Surgical Titanium Mesh System Angled End Rings

- Pathway: 510(k) (Special)
- Applicant: Blackstone Medical, Inc.
- Decided: Oct 9, 2003 after 37 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: 2 generations back to K003275 (2001). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030744: Blackstone Surgical Titanium Mesh, Blackstone Medical, Inc. (2003) Summary page 1.

## Most influential descendants
- K061578: SSP Vertebral Body Replacement (2006), 0 descendants of its own

## Indications for use
The Blackstone Medical Surgical Titanium Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Surgical Titanium mesh is also indicated for treating fractures of the thoracic and lumbar spine. The Surgical Titanium Mesh System 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. It is recommended to pack bone graft material inside the mesh cage prior to implantation. The Surgical Titanium Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used with the Surgical Titanium Mesh System is the Blackstone Medical Spinal Fixation System.

Source page: https://510kreport.com/device/K032700
Methodology: https://510kreport.com/methodology