Medical Device News Magazine

Wednesday, March 22, 2023

Precision Spine Reports the National Release of the Reform® Ti HA Coated Pedicle Screw System

Precision Spine, Inc., a medical device company dedicated to Made-in-the-USA manufacturing, has introduced nationally the Reform® Ti HA Coated Pedicle Screw System, which provides surgeons with the increased flexibility and versatility that is required during today’s challenging degenerative and trauma spine procedures.

The patent-pending Reform Ti 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. In a study conducted at Kawasaki Medical School’s Department of Orthopedic Surgery in Okayama, Japan, Hasegawa, Inafusa, Mikawa, Lim and An evaluated the effect of hydroxyapatite (HA) coating on the pedicle screw in the osteoporotic lumbar spine and investigated the relationship between resistance against the screw pull-out force and bone mineral density (BMD) of the vertebral body. Their findings concluded that the resistance to the pull-out force of HA-PS is 1.6 times that of Ti-PS. Furthermore, HA-PS has superior biological bonding to the surrounding bone, as early as 10 days after surgery in this osteoporotic spine model.

The Reform Ti HA Coated Pedicle Screw System features a titanium tulip and a triple lead thread to deliver strength, stability, and efficiency to all thoracolumbar constructs. A modified proximal tapered thread design increases bone screw interface, which enhances pull-out strength while reducing insertion torque. A more aggressive self-starting tip, combined with the system’s T25 drive feature, enables surgeons to achieve more immediate bone engagement and maximum control during insertion. Hexalobular drive fittings on the bone screw and locking cap help reduce the incidence of toggle and stripping. The square threaded locking cap geometry is designed to reduce the risk of cross-threading.

“The system’s low-profile titanium tulip gives surgeons increased space for fusion,” said Vikram Udani M.D., “while decreasing the potential risk of adjacent segment facet impingement. The screw’s triple lead thread is extremely efficient and reduces overall surgeon fatigue, especially in longer constructs.”

“The Reform Ti HA System joins the rest of our Reform family of devices to bring advanced versatility, efficiency and cost-effectiveness to the OR,” said Chris DeNicola, Chief Operating Officer of Precision Spine.

The Reform Ti HA 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. 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.

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