Camber Spine receives FDA clearance for titanium ALIF device: 3 insights

Shayna Korol -   Print  |

Camber Spine received FDA 510(k) clearance to market its ENZA-A Titanium Anterior Lumbar Interbody Fusion system, a minimally invasive interbody fusion device for integrated fixation.

Here are three things to know:

1. The interbody fusion device consists of a 3D printed titanium body with a roughened surface engineered to encourage bone growth onto the device's cranial and caudal surfaces. The upper and lower faces are designed with pores averaging 500 microns in diameter.

2. The device has multiple openings to allow a large volume of autogenous bone graft to be packed into the implant to further facilitate fusion. Like Camber Spine's original ENZA, this device features two sharpened anchor plates within the 3D-printed body which are deployed into the adjacent vertebrae to provide fixation.

3. The ENZA-A Titanium ALIF is indicated for use with autogenous bone graft in patients with degenerative disc disease at one or two contiguous levels from L2 to S1. It is intended to be used with additional FDA-cleared supplementary fixation systems. The implants may be implanted using a laparoscopic or an open anterior approach.

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