# K081332: Athlet Vertebral Body Replacement System

- Pathway: 510(k) (Special)
- Applicant: Signus Medizintechnik GmbH
- Decided: Jun 10, 2008 after 29 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The ATHLETTM System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from TI to L5). The ATHLETTM system is intended for use with supplemental internal fixation and intended to be implanted in pairs.

Source page: https://510kreport.com/device/K081332
Methodology: https://510kreport.com/methodology