# K040168: Modification to Geo Structure

- Pathway: 510(k) (Special)
- Applicant: Interpore Cross Intl.
- Decided: Apr 8, 2004 after 73 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
No predicates in its family tree.
239 later devices descend from it; 2 cite it directly.
0 of 240 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K050861: Peek Cas (2005), 224 descendants of its own
- K091381: Ibex Spinal System (2009), 181 descendants of its own
- K110650: Zyston Arc Interbody Spacer (2011), 177 descendants of its own
- K112014: Zyston Straight Spacer System (2011), 174 descendants of its own
- K122989: Biomet Lateral Spacer System (2012), 171 descendants of its own

## Recalls of this device
- Jan 14, 2005 · Not classified · Z-0530-05: Mislabeled.

## Indications for use
The GEO Structure is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The GEO Structure is also indicated for treating fractures of the thoracic and lumbar spine. The GEO Structure is designed to restore the biomechanical integrity of the anterior middle and posterior spinal column even in the absence of fusion for a prolonged period.

Source page: https://510kreport.com/device/K040168
Methodology: https://510kreport.com/methodology