# K020048: Modification to Geo Structure

- Pathway: 510(k) (Special)
- Applicant: Interpore Cross Intl.
- Decided: Feb 6, 2002 after 30 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 K010530 (2001). 1 ancestor in all.
1,559 later devices descend from it; 3 cite it directly.
2 of 1,561 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010530: Geo Structure, Interpore Cross Intl. (2001) Summary page 1.

## Most influential descendants
- K031914: Spinal Concepts, Inc. Cadence and Fortitude (2003), 1,530 descendants of its own
- K033517: Spinal Concepts Inc. Cadence and Traxis (2004), 1,528 descendants of its own
- K062759: Paramount VBR System (2007), 1,406 descendants of its own
- K072120: Paramount Intervertebral Body Fusion Device (2007), 1,405 descendants of its own
- K073291: Capstone Spinal System (2008), 1,103 descendants of its own

## 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/K020048
Methodology: https://510kreport.com/methodology