The US Food and Drug Administration (FDA) has given 510(k) clearance to Camber Spine to market its ENZA-A titanium anterior lumbar interbody fusion (ALIF) system, a unique, minimally invasive interbody fusion device providing integrated fixation.
ENZA-A Titanium ALIF is an interbody fusion device consisting of a 3D printed titanium body with a roughened surface that encourages bone growth onto the cranial and caudal surfaces of the device. The upper and lower faces are designed with pores that average 500 microns in diameter; this is the optimal environment for bone to grow and fully incorporate the implant within the vertebral bodies, a press release states.
The ENZA-A Titanium ALIF has multiple openings to allow a large volume of autogenous bone graft to be easily packed into the implant to further facilitate fusion. Similar to the original ENZA, this device features two sharpened anchor plates that are housed within the 3D-printed body until they are deployed into the adjacent vertebrae to provide fixation.
The ENZA-A is the second device in the Camber Spine ENZA-line of implants.
The implant is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. It is intended to be used with additional FDA-cleared supplementary fixation systems. These implants may be implanted via a laparoscopic or an open anterior approach, the company states.