# K063205: Atlas Spine Vertebral Body Replacement

- Pathway: 510(k) (Traditional)
- Applicant: Atlas Spine, LLC
- Decided: Feb 26, 2007 after 126 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K091406: Atlas Spine Spacer (2009), 6 descendants of its own
- K100743: Atlas Spine Pivoting System (2010), 4 descendants of its own
- K172419: Velofix™ TLIF Cage (2017), 2 descendants of its own
- K181829: Velofix TLIF Cage (2018), 1 descendant of its own
- K243816: Testa TP Pivoting Spacer System (2025), 0 descendants of its own

## Recalls of this device
- Jul 26, 2013 · Class II · Z-1616-2016: The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.

## 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. The device must be used with supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5).

Source page: https://510kreport.com/device/K063205
Methodology: https://510kreport.com/methodology