# K033702: Blackstone Peek Vertebral Body Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Blackstone Medical, Inc.
- Decided: Mar 31, 2004 after 127 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.
1,036 later devices descend from it; 4 cite it directly.
1 of 1,040 devices in its family (counting itself) has 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
- 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
- K041939: Blackstone Peek Vertebral Body Replacement System Lordotic Lateral Spacers (2004), 718 descendants of its own

## Indications for use
The Blackstone VBR device is indicated for use in the thoraco-lumbar 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 Blackstone VBR device is also indicated for treating fractures of the thoracic and lumbar spine. The Blackstone VBR device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for prolonged period. Additionally, the VBR device is intended to be used with bone graft. a The Blackstone VBR device is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used is the Blackstone Spinal Fixation System.

Source page: https://510kreport.com/device/K033702
Methodology: https://510kreport.com/methodology