US FDA clears Camber Spine’s Enza ALIF device


Camber Spine Technologies has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Enza zero profile anterior interbody fusion (ALIF) system, a unique, minimally invasive interbody fusion device providing integrated fixation.  This clearance marks Camber’s eighth line of spinal implant systems to be released in the US market.

The Enza zero profile ALIF 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. The Enza bladed stabilisation system, utilises a simple, one-step insertion and fixation method through a minimally invasive approach to achieve interbody fusion.

This comes shortly after two new products were launched by the company; the Prolix sacroiliac joint fusion system and the Orthros minimally invasive posterioir stabilisation system.

The Prolix system uses an inferior approach between the posterior superior iliac spine and the posterior inferior iliac spine.

A machined cortical bone spacer is implanted between the sacrum and ilium through a special cannula. The space is intended to be 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 sacroiliac pain, according to a company release.

The Orthros MIS posterior stabilisation system includes breakaway screw head extensions designed to facilitate the minimally invasive technique.

The pedicle screws are designed to provide rod reduction within the screw head. The system is intended to allow 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, according to the release, should further facilitate an MIS technique. 

There are four different dilation options, intended to reduce the number of steps used to implant each pedicle screw. According to the company release, Neuromonitoring can be performed through the PEEK dilators and tap sleeve.