# K040928: Expandable Peek VBR Implant

- Pathway: 510(k) (Traditional)
- Applicant: Interpore Cross Intl.
- Decided: Aug 27, 2004 after 140 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
No predicates in its family tree.
1,504 later devices descend from it; 10 cite it directly.
1 of 1,505 devices in its family (counting itself) has 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
- K042930: Spacevision Cage System (2004), 1,440 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
- K100175: Clydesdale Spinal System (2010), 1,008 descendants of its own

## Indications for use
The Expandable PEEK VBR Implant is indicated for use in the thoracolumbar spine (i.e., TI 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 Expandable PEEK VBR Implant is also indicated for treating fractures of the thoracic and lumbar spine. The Expandable PEEK VBR Implant 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/K040928
Methodology: https://510kreport.com/methodology