Camber Spine wins FDA nod for combining existing tech
Camber Spine Technologies has won 510(k) clearance from the FDA to market its ENZA-A Titanium Anterior Lumbar Interbody Fusion (ALIF) system, which leverages two of its existing technologies.
The new device borrows from the Wayne, Penn.-based company’s first-generation ENZA, which has dual-grip anchor technology, and from its Spira line, which use spiral support arches to increase fusion rates and stabilization. The FDA approved the original Spira device in August 2017.
ENZA-A is indicated for use with autogenous bone graft in patients with degenerative disc disease at one or two contiguous levels from L2 to S1 and is is intended to be used with additional FDA-cleared supplementary fixation systems implanted via a laparoscopic or an open anterior approach.
ENZA-A Titanium ALIF consists of a 3D printed titanium body with a roughened surface that encourages bone growth onto the cranial and caudal surfaces of the device, according to the company. The upper and lower faces are deliberately designed with pores that average 500 microns in diameter, the optimal environment for bone to grow and fully incorporate the implant with the vertebral bodies. It has multiple openings to allow a large volume of autogenous bone graft to be packed into the implant to further facilitate fusion. Similar to the original ENZA, it has two sharpened anchor plates housed within the 3D-printed body until they are deployed into the adjacent vertebrae to provide fixation.
The new ENZA was designed to be minimally invasive with single, inline instrumentation to insert the device, deploy the anchor plates, and lock it in place. Camber Spine expects to launch additional products later this year. This interbody, coupled with additional product launches expected later this year in the cervical and lateral markets, will continue to grow Camber Spine’s presence as a market leader and innovator in minimally invasive spine surgery technology advancements.”