FDA Product Code MQP: Spinal Vertebral Body Replacement Device
FDA product code MQP covers spinal vertebral body replacement devices used to reconstruct the anterior column of the spine.
These expandable or fixed-height titanium or PEEK cages are used to replace one or more vertebral bodies removed due to tumor, infection, trauma, or deformity, restoring anterior column support and spinal alignment while facilitating fusion.
MQP devices are Class II medical devices, regulated under 21 CFR 888.3060 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Signature Orthopaedics Pty, Ltd., Alphatec Spine, Inc. and Icotec AG.
FDA 510(k) Cleared Spinal Vertebral Body Replacement Device Devices (Product Code MQP)
About Product Code MQP - Regulatory Context
510(k) Submission Activity
277 total 510(k) submissions under product code MQP since 1999, with 277 receiving FDA clearance (average review time: 114 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 5 in the prior period.
FDA Review Time
Recent submissions under MQP have taken an average of 135 days to reach a decision - up from 114 days historically. Manufacturers should account for longer review timelines in current project planning.
MQP devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →