# K050348: CO Vertebral Body Replacement

- Pathway: 510(k) (Special)
- Applicant: Scient'X
- Decided: May 27, 2005 after 105 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 K841189 (1984). 12 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033109: Ellys and Aurys Vertebral Body Replacements, Scient'X (2004) Summary page 1.

## Most influential descendants
- K061752: Spinal Usa VBR System (2006), 0 descendants of its own
- K053292: Davantis/Antelys Vertebral Body Replacements (2006), 0 descendants of its own

## Indications for use
CO Vertebral Body Replacements are vertebral body replacements for use in the lumbar and thoracic spine (TI-L5) to replace a damaged, collapsed or unstable vertebral body due to tumor or trauma (i.e. fiacture). These are not stand-alone devices, ISOBAR 06.2 Hemispherical Screws with Offset Clamps and 05.5 Rods must be utilized to enhance the stability of the reconstruction in skeletally mature patients following full or partial corpectomy.

Source page: https://510kreport.com/device/K050348
Methodology: https://510kreport.com/methodology