Precision Spine Introduces New Modular Screw System

Precision Spine Inc. has launched the Reform Ti FS Modular Fenestrated Screw System, a product that provides cement augmentation in hard-to-fuse cases.

In patients with osteoporotic bone, standard pedicle screws can loosen and pull out. The same outcome arises from tumor resection and cases where cancellous purchase is compromised. The Reform Ti FS system delivers PMMA bone cement through the screw shaft directly into the vertebral body, with three exit ports spaced 120 degrees around the shaft for symmetric distribution, according to the company. With its modular tulip design, the Reform Ti FS Fenestrated Screw System is compatible with the Reform Ti and Reform Ti MIS CT systems.

“This addition to our Reform family of products broadens the breadth of indications that can be addressed by offering surgeons the ability to provide stabilization in compromised bone while still utilizing the advanced features of the Reform Ti System,” Precision Spine President/CEO Chris DeNicola said.

The Reform Pedicle Screw System immobilizes and stabilizes the spine; it is an adjunct to fusion in treating various acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, including: degenerative disc disease (defined by back pain of discogenic origin with disc degeneration confirmed by patient history and radiographic studies); spondylolisthesis; trauma (fracture or dislocation); spinal stenosis; curvatures (scoliosis, kyphosis; and/or lordosis); spinal tumor; pseudarthrosis; and failed previous fusion.

“As the spinal patient population lives longer, and the rate of malnourished obesity increases, osteoporosis has become a common pitfall to successful surgical outcomes.  Although our diagnostics for osteoporosis and medical management of the disease are improving, the cost of treatment and the lengthy time needed to see improvement in bone quality are significant barriers,” stated Dr. Stefan Renaud, an orthopedic surgeon at Caromont Regional Medical Center in Gastonia, N.C. “For urgent surgical needs, and for undiagnosed intraoperative osteopenia/osteoporosis there is only one currently viable option, and that is cement augmentation. The fenestrated screw system from Precision Spine has been a lifeline. Whether in open or percutaneous screw constructs, this system has worked flawlessly on dozens of cases to prevent loss of purchase in deformity correction, or to bail me out from unexpected poor bone quality in fracture stabilization. I have had zero loss of fixation, when using this system.” 

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Reform Pedicle Ti Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis.

When used with G21 V-Fast or V-Steady Bone Cement and PicoMix V and/or V-HP Gun with the G21 and Precision Spine Cement Cannula for mixing and injecting bone cements, the fenestrated Reform Ti pedicle screws can restore spinal column integrity even without fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine. The fenestrated Reform pedicle screws augmented with G21 V-Fast or V Steady Bone Cement can be used at spinal levels where the spine’s structural integrity is not severely compromised. 

Precision Spine, Inc. is a privately held company headquartered in Parsippany, N.J., with manufacturing facilities in Pearl, Miss. Precision Spine provides domestically produced spinal products that help treat serious orthopedic conditions cost-effectively.