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September 17, 2015

Precision’s Reform Modular and HA coated pedicle screw systems gets FDA approval

The US Food and Drug Administration (FDA) has granted approval for Precision Spine's Reform modular and HA (hydroxyapatite) coated pedicle screw systems.

The US Food and Drug Administration (FDA) has granted approval for Precision Spine’s Reform modular and HA (hydroxyapatite) coated pedicle screw systems.

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

It has been developed to offer 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.

"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 system’s modularity is intended to help increase the surgeon’s visibility in order to permit more thorough decortication of the surrounding fusion bed.

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."

It 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.

The company noted that all components are available in a variety of sizes, allowing them to be suitable for each patient’s anatomy.

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

Last October, the company secured 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.

The device’s plate/cage integrated design helps in rigid screw fixation using a zero profile construct.

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