# K062666: Vusion TS, PS, and CS Partial Vertebral Body Replacements

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Jan 25, 2007 after 140 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K111965: Vusion (R) OS (2011), 0 descendants of its own

## Indications for use
The VusionTM implants are intended for use in partial spine vertebrectomy procedures for vertebral body replacement. The indications include replacement of a collapsed, damaged, or unstable vertebral body that must be resected or excised due to tumor or trauma. The implants are intended for use with a supplemental rod or plate fixation system.

Source page: https://510kreport.com/device/K062666
Methodology: https://510kreport.com/methodology