FDA Approval for Precision Spine’s Reform® Modular and HA Coated Pedicle Screw Systems

Precision Spine, Inc. has received FDA approval of its Reform® Modular and HA (hydroxyapatite) Coated Pedicle Screw Systems.

Background

The Reform® Pedicle Screw 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. While it might look like this is just another Pedicle Screw approval, precision Spine’s Reform® represents the first modular system on the market to feature a cobalt chrome tulip with a proximal tapered triple lead thread. This 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® HA Coated Pedicle 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.

Precision Spine says all components are available in a variety of sizes to help more closely match each patient’s anatomy. The system is intended 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.

Company comments 

“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.”

Source: Business Wire

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