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., Spineart and Medacta International S.A..
List of Bone Cement, Posterior Screw Augmentation devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Bone Cement, Posterior Screw Augmentation devices (product code PML). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →