Camber Spine Announces New Launches and FDA Clearance

Camber Spine Technologies has launched Prolix and Orthros MIS spine systems.

In a May 9, 2016 announcement, the company says it believes its Prolix SI fusion system is the “first true fusion product designed to treat Sacro-Iliac pain.”

The system, according to the company, utilizes a “safe inferior approach between the posterior superior iliac spine (PSIS) and the posterior inferior iliac spine (PIIS). A machined cortical bone spacer is implanted between the sacrum and ilium through a special cannula. The space is now treated like a discectomy to help promote fusion as opposed to only limiting motion of the joint when solely using lateral screws.”

Prolix, used in conjunction with lateral screws, has the potential to decrease the opportunity for revisions by providing a true fusion technique to the spinal implant market to treat Sacro-Iliac pain.

The Orthros MIS Posterior Stabilization System is the latest addition to the company’s pedicle screws line. The MIS [minimally invasive surgery] version of the system includes breakaway screw head extensions which facilitate the MIS technique. The screws are designed to provide rod reduction within the screw head.

“An effective instrument combination for compression and distraction enables the surgeon to adjust the spinal segments instead of toggling polyaxial screw heads. The Rod Inserters are some of the most rigid and small stature Inserters on the market which further facilitate an MIS technique. The system provides a flexibility unlike any other to promote the different techniques used for MIS surgery. There are four different Dilation options which can reduce the number of steps used to implant each pedicle screw and neuro-monitoring is easily performed through the PEEK Dilators and Tap Sleeve.”

Camber President and COO Wendy DiCicco said, “These two products are the face of the new Camber Spine, launching market changing products to the industry for improvements in patient care. These products are just the first in a series of innovative products to come in 2016.”

ALIF FDA Clearance

On May 9, the company also announced that it received 510(k) clearance from the FDA to market its Enza Zero Profile Anterior Interbody Fusion (ALIF) system, “a unique, minimally invasive interbody fusion device providing integrated fixation.” The company says the clearance marks its eighth line of spinal implant systems to be released in the U.S. market.

The system is intended for use in patients with degenerative disc disease at one or two contiguous levels from L2 to S1. The system is intended for use with bone graft and with supplemental fixation systems.