# K190147: COLOSSEUM Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: May 8, 2019 after 99 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: 15 generations back to K841189 (1984). 63 ancestors in all.
No later device cites it as a predicate yet.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162315: FORTIFY Corpectomy Spacers, Globus Medical, Inc. (2017) Summary page 4.
- K112756: Fortify (TM) and Fortify (TM)-R Corpectomy Spacers, Globus Medical, Inc. (2011) Summary page 4.
- K173982: FORTIFY Corpectomy Spacers, Globus Medical, Inc. (2018) Summary page 4.
- K041389: Synthes Contoured Synmesh Spacer, Synthes Spine (2004) Summary page 4.

## Indications for use
When used as a vertebral body replacement device in the cervical spine (C2-T1), COLOSSEUM™ Mesh devices are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion. When used as a vertebral body replacement device in the thoracolumbar spine (T1-L5), COLOSSEUM™ Mesh devices are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The interior of the vertebral body replacement device spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion. These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

Source page: https://510kreport.com/device/K190147
Methodology: https://510kreport.com/methodology