FDA Product Code PML: Bone Cement, Posterior Screw Augmentation
Under FDA product code PML, posterior pedicle screw augmentation bone cements are cleared to enhance screw fixation in osteoporotic or compromised bone.
These injectable calcium phosphate or PMMA cements are delivered through cannulated pedicle screws to fill the surrounding cancellous bone and increase the pullout strength of the screw, particularly in elderly patients with osteoporosis where standard fixation may be insufficient.
PML devices are Class II medical devices, regulated under 21 CFR 888.3027 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Alphatec Spine, Inc., Icotec AG and Spineart.
FDA 510(k) Cleared Bone Cement, Posterior Screw Augmentation Devices (Product Code PML)
About Product Code PML - Regulatory Context
510(k) Submission Activity
18 total 510(k) submissions under product code PML since 2016, with 18 receiving FDA clearance (average review time: 147 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 PML have taken an average of 96 days to reach a decision - down from 154 days historically, suggesting improved FDA processing for this classification.
PML devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →