FDA approval for Precision Spine’s Reform modular and HA-coated pedicle screw systems


Precision Spine has received Food and Drug Administration approval of its Reform modular and HA (hydroxyapatite)-coated pedicle screw systems.

The Reform modular pedicle screw system represents the first modular system on the market to feature a cobalt chrome tulip with a proximal tapered triple lead thread, which is designed to help increase the bone/screw interface to enhance pull-out strength and allow for efficient screw delivery. The system’s modularity is intended to help increase the surgeon’s visibility in order to permit more thorough decortication of the surrounding fusion bed.

The patent-pending Reform screws have a hydroxyapatite coating applied to the screw threads that is designed to enhance the amount of fixation possible between the pedicle screw and the surrounding bone in osteoporotic patients.

“The Reform system is one of the most comprehensive and versatile top loading pedicle screw systems available,” said Chris DeNicola, executive vice president of Operations for Precision Spine. “With the addition of the modular and HA-coated products, Reform now offers more ways to help surgeons best meet their patients’ complex spinal pathologies.”

The Reform system is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, hooks, dominoes and lateral offsets. All components are available in a variety of sizes to help more closely match each patient’s anatomy. The system is intended to provide immobilisation and stabilisation of spinal segments of skeletally mature patients as an adjunct to fusion in the treatment of the many acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.