# K051105: Basis Vertebral Body Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Jun 9, 2005 after 38 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: 6 generations back to K003155 (2001). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033926: Hourglass Vertebral Body Spacer, Medtronic Sofamor Danek (2004) Summary page 2.

## Indications for use
When used as a vertebral body replacement, BASIS™ Vertebral Body Spacers are intended to be used in partial corpectomy procedures to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1-L5) to replace and restore height of a resected vertebral body or portion thereof, excised for the treatment of tumor or trauma (i.e., fracture). BASIS™ Vertebral Body Spacers must be used with supplemental fixation. Additionally, BASIS™ Vertebral Body Spacers are intended to be used with bone graft.

Source page: https://510kreport.com/device/K051105
Methodology: https://510kreport.com/methodology