# K051246: Construx Mini Peek VBR System

- Pathway: 510(k) (Traditional)
- Applicant: Blackstone Medical, Inc.
- Decided: Jun 14, 2005 after 29 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: 7 generations back to K841189 (1984). 27 ancestors in all.
834 later devices descend from it; 4 cite it directly.
1 of 862 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.
- K033702: Blackstone Peek Vertebral Body Replacement System, Blackstone Medical, Inc. (2004) Summary page 1.
- K043316: Rabea Spinal Implant, Signus Medizintechnik GmbH (2005) Summary page 1.
- K042714: Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4, Spine Next America Corporation (2004) Summary page 1.

## Most influential descendants
- 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
- K123045: Brigade Standalone System (2013), 696 descendants of its own
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own

## Indications for use
The Construx TM Mini PEEK VBR System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of 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 ConstruxTM Mini PEEK VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The Construx TM Mini PEEK VBR 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 of time. The VBR device is intended to be used with bone graft material The Construx TM Mini PEEK VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used with the PEEK VBR System is the Blackstone Medical Spinal Fixation System.

Source page: https://510kreport.com/device/K051246
Methodology: https://510kreport.com/methodology