LDR Receives 510(k) for Spinal Transforaminal Approach Implant

LDR Holding, a company out of Austin, TX that manufactures devices for fusion and non-fusion spine surgery, has received FDA approval for its latest partial vertebral body replacement device called ROI-T™.

The ROI-T™ is a transforaminal approach implant with an anatomic shape that conforms to the anterior vertebral body, the minimal width and tapered end of the device facilitating insertion through a small opening. The open interior cavity allows for substantial graft amounts.
The ROI-T™ device is made of PEEK-Optima® for biocompatibility and radiolucency along with Tantalum markers for verification of implant positioning. The system is comprised of multiple lordotic angles and heights for optimized fit per anatomical requirements. An innovative inserter holds the implant, providing full support of the device during impaction.

Here’s a company video demonstrating the ROI system: