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Precision Spine obtains FDA approval for Reform Modular and HA coated pedicle screw systems

Precision Spine has obtained approval from the US Food and Drug Administration (FDA) for its Reform Modular and HA (hydroxyapatite) coated pedicle screw systems.

Reform

The system has been developed to provide immobilization and stabilization 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.

Precision Spine operations executive vice-president Chris DeNicola said: "The Reform system is one of the most comprehensive and versatile top loading pedicle screw systems available.

"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 and posterior spinal fixation system that includes pedicle screws, rods, cross-connectors, locking cap screws, hooks, dominoes and lateral offsets.

According to the firm, all components are available in a variety of sizes, allowing them to be suitable for each patient’s anatomy.

The Reform Modular pedicle screw system features a cobalt chrome tulip with a proximal tapered triple lead thread, which has been developed to increase the bone/screw interface to enhance pull-out strength and allow for effective screw delivery.

The patent-pending system also features a hydroxyapatite coating applied to the screw threads, which enhances the amount of fixation possible between the pedicle screw and the surrounding bone in osteoporotic patients.

In October 2014, Precision Spine received FDA 510(k) approval for the VAULT-C Anterior Cervical Interbody Fusion Device, which was developed to be used by skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one disc level.


Image: The Reform system is a top-loading, multiple component and posterior spinal fixation system. Photo: courtesy of renjith krishnan/ FreeDigitalPhotos.net.