# K112429: Giza (R) Vertebral Body Replacement

- Pathway: 510(k) (Traditional)
- Applicant: Eden Spine, LLC
- Decided: Jan 26, 2012 after 156 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K003275 (2001). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012254: VBR, Osteotech, Inc. (2001) Summary page 1.
- K060416: Obelisc Vertebral Body Replacement Device, Ulrich GmbH & Co. KG (2006) Summary page 1.

## Most influential descendants
- K192214: CarboClear VBR System (2019), 1 descendant of its own
- K222874: CarboClear Cervical Cage System, CarboClear Cervical VBR System (2023), 0 descendants of its own

## Recalls of this device
- Mar 17, 2017 · Class II · Z-2072-2017: Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw.

## Indications for use
The Giza® Vertebral Body Replacement is intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g. fracture). The Giza® Vertebral Body Replacement is intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The use of allograft or autograft with the Giza® Vertebral Body Replacement device is optional.

Source page: https://510kreport.com/device/K112429
Methodology: https://510kreport.com/methodology