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.

Go deeper with GlobalData

Go deeper with GlobalData

The gold standard of business intelligence.

Find out more

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

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."

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

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.

Medical Device Network Excellence Awards - Nominations Closed

Nominations are now closed for the Medical Device Network Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact

Excellence in Action
Awarded for Innovation in Remote Hearing Diagnostics , hearX’s Self Test Kit (STK) delivers clinically validated audiometry via smart devices, enabling remote, scalable hearing assessments in homes, clinics and retail. Learn how hearX is redefining hearing care delivery and reducing costs for providers globally.

Discover the Impact