# K012254: VBR

- Pathway: 510(k) (Traditional)
- Applicant: Osteotech, Inc.
- Decided: Oct 16, 2001 after 90 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: 1 generation back to K003155 (2001). 1 ancestor in all.
2,058 later devices descend from it; 18 cite it directly.
2 of 2,060 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003155: Vertebral Body Replacement, Osteotech, Inc. (2001) Summary page 2.
- (no number) OEC/Rezaian Spinal Fixator: named in the summary without a submission number
- (no number) DePuy Acromed Stackable: named in the summary without a submission number

## Most influential descendants
- 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
- K043479: MC+ Partial VBR (2005), 1,214 descendants of its own

## Indications for use
The VBR™ is a vertebral body replacement device intended for use in the thoracic and lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VBR™ is intended to be used with supplemental internal spinal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Such systems include posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems. The use of bone grafting material with the VBR™ is optional.

Source page: https://510kreport.com/device/K012254
Methodology: https://510kreport.com/methodology