FDA Product Code MQV: Filler, Bone Void, Calcium Compound
Under FDA product code MQV, calcium compound bone void fillers are cleared for use in orthopedic and spinal surgery.
These synthetic graft materials — including calcium phosphate, calcium sulfate, and hydroxyapatite formulations — are used to fill bone defects created by trauma, tumor resection, or surgical procedures. They resorb over time as new bone grows to replace them.
MQV devices are Class II medical devices, regulated under 21 CFR 888.3045 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Orthocon, Inc., Kuros Biosciences B.V and SeaSpine Orthopedics Corporation.
FDA 510(k) Cleared Filler, Bone Void, Calcium Compound Devices (Product Code MQV)
About Product Code MQV - Regulatory Context
510(k) Submission Activity
490 total 510(k) submissions under product code MQV since 1996, with 490 receiving FDA clearance (average review time: 148 days).
Submission volume has remained relatively stable over the observed period, with 34 submissions in the last 24 months.
FDA Review Time
Recent submissions under MQV have taken an average of 102 days to reach a decision - down from 152 days historically, suggesting improved FDA processing for this classification.
MQV devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →