# K003155: Vertebral Body Replacement

- Pathway: 510(k) (Traditional)
- Applicant: Osteotech, Inc.
- Decided: Jan 4, 2001 after 86 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.
2,091 later devices descend from it; 7 cite it directly.
2 of 2,092 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012254: VBR (2001), 2,058 descendants of its own
- K021791: Verte-Stack Spinal System (2002), 2,047 descendants of its own
- K023570: Modification to Verte-Stack Spinal System (2002), 1,383 descendants of its own
- K031780: Verte-Stack Spinal System (2003), 1,326 descendants of its own
- K033109: Ellys and Aurys Vertebral Body Replacements (2004), 1,218 descendants of its own

Source page: https://510kreport.com/device/K003155
Methodology: https://510kreport.com/methodology