# K030744: Blackstone Surgical Titanium Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Blackstone Medical, Inc.
- Decided: Jun 27, 2003 after 109 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: 1 generation back to K003275 (2001). 2 ancestors in all.
1,040 later devices descend from it; 5 cite it directly.
1 of 1,043 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003275: Synthes Synmesh Spacer System, Synthes (Usa) (2001) Summary page 1.
- K003709: Surgical Dynamics Mesh Cage System, United States Surgical, A Division of Tyco Healthc (2001) Summary page 1.

## Cited in the summary but kept off the family tree
- K030043: DePuy AcroMed Surgical Titanium Mesh System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K033702: Blackstone Peek Vertebral Body Replacement System (2004), 1,036 descendants of its own
- K051246: Construx Mini Peek VBR System (2005), 834 descendants of its own
- K060350: Construx PL/TL Peek Partial VBR System (2006), 754 descendants of its own
- K081849: Blackstone Pillar SA Partial Vertebral Body Replacement Device (2008), 753 descendants of its own
- K100043: Coroent XLR Standalone System (2010), 744 descendants of its own

## Indications for use
The Blackstone Medical Surgical Mesh System is indicated for use in the thoracolumbar spine (Tl-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 Mesh is also indicated for treating fractures of the thoracic and lumbar spine. The Surgical 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 Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used with the Surgical Mesh System is the Blackstone Medical Spinal Fixation System.

Source page: https://510kreport.com/device/K030744
Methodology: https://510kreport.com/methodology