# K050861: Peek Cas

- Pathway: 510(k) (Special)
- Applicant: Interpore Cross Intl.
- Decided: May 27, 2005 after 52 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 K040168 (2004). 2 ancestors in all.
224 later devices descend from it; 3 cite it directly.
0 of 227 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040928: Expandable Peek VBR Implant, Interpore Cross Intl. (2004) Summary page 1.
- K040168: Modification to Geo Structure, Interpore Cross Intl. (2004) Summary page 1.

## Most influential descendants
- 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
- K151310: Amendia Interbody Fusion Devices (2016), 169 descendants of its own

## Indications for use
The PEEK CAS is indicated for use in the thoracolumbar spine (i.e., TI to L5) for partial replacement of 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 PEEK CAS is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The PEEK CAS 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/K050861
Methodology: https://510kreport.com/methodology