# K190349: MediExpand TL Expandable VBR System

- Pathway: 510(k) (Traditional)
- Applicant: Cmf Medicon Surgical, Inc.
- Decided: Oct 24, 2019 after 252 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: 5 generations back to K841189 (1984). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142205: NuVasive X-CORE (R) Expandable VBR System, Nuvasive, Inc. (2015) Summary page 4.
- K083186: Aesculap Hydrolift VBR System, Aesculap Implant System, Inc. (2010) Summary page 4.

## Indications for use
The MediExpand TL Expandable VBR System is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore the height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neutral tissues. The MediExpand TL Expandable VBR System is intended to be used with supplemental internal spinal fixations systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon’s discretion.

Source page: https://510kreport.com/device/K190349
Methodology: https://510kreport.com/methodology