# K061752: Spinal Usa VBR System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal USA
- Decided: Aug 15, 2006 after 55 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). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042201: Novel VBR Spinal System, Alphatec/Nexmed (2004) Summary page 1.
- K052384: Lanx VBR System, Lanx, LLC (2005) Summary page 1.
- K990148: Stackable Cage System, Depuy Motech Acromed (1999) Summary page 1.
- K050449: Quantum Vertebral Body Replacement, Quantum Orthopedics, Inc. (2005) Summary page 1.
- K031757: Peek Tetris Spinal Implant, Signus Medical, LLC (2003) Summary page 1.
- K050348: CO Vertebral Body Replacement, Scient'X (2005) Summary page 1.
- K033109: Ellys and Aurys Vertebral Body Replacements, Scient'X (2004) Summary page 1.

## Indications for use
The Spinal USA VBR System is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The Spinal USA VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column The Spinal USA VBR System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). In addition, the Spinal USA VBR System is intended for use with bone graft.

Source page: https://510kreport.com/device/K061752
Methodology: https://510kreport.com/methodology