# K063464: Atlas Spine Vertebral Body Replacement

- Pathway: 510(k) (Traditional)
- Applicant: Atlas Spine, Inc.
- Decided: Mar 9, 2007 after 113 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). 28 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050553: Novel VBR Spinal System, Alphatec/Nexmed (2005) Summary page 1.
- K043206: Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer), Pioneer Surgical Technology (2005) Summary page 1.
- K061151: Pioneer Vertebral Spacer (Vertebral Spacer), Pioneer Surgical Technology (2006) Summary page 1.
- K050449: Quantum Vertebral Body Replacement, Quantum Orthopedics, Inc. (2005) Summary page 1.
- K052641: Modification to:  Quantum Vertebral Body Replacement, Quantum Orthopedics, Inc. (2006) Summary page 1.
- K061576: Modification to Quantum Vertebral Body Replacement System, Quantum Orthopedics, Inc. (2006) Summary page 1.
- K062004: Modification to Quantum Vertebral Body Replacement, Quantum Orthopedics, Inc. (2006) Summary page 1.

## Most influential descendants
- K081880: Atlas Spine Spacer (2008), 0 descendants of its own
- K071497: Atlas Spine Vertebral Body Replacement (2007), 0 descendants of its own

## Indications for use
The Atlas Spine Vertebral Body Replacement (VBR) is intended for use in the thoracolumbar spine (T1-L5) for partial or complete replacement (i.e., vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Atlas Spine VBR is also indicated for treating fractures of the thoracic and lumbar spine. The Atlas Spine VBR 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 interior of the Atlas Spine VBR can be packed with bone. This device 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).

Source page: https://510kreport.com/device/K063464
Methodology: https://510kreport.com/methodology