Pinnacle Spine Files to Market InFill with HA-Enhanced PEEK OPTIMA

By Julie A. Vetalice

Pinnacle Spine filed for FDA 510(k) clearance to market InFill® Lateral Lumbar Fusion systems with Invibio's HA Enhanced PEEK-OPTIMA material. Clearance is expected in 4Q17.

The InFill device has been manufactured from PEEK since its initial version, cleared in 2011. Hydroxyapatite enhancement brings the support of osteoconductivity that encourages bone ongrowth on all surfaces, while providing reduced stress shielding, artifact-free imaging, etc.

Pinnacle Spine holds a number of U.S. and non-U.S. patents and patent applications, including those filed in Australia, Canada and Europe. Most recently, the company was granted a U.S. patent addressing implant delivery that lets bone graft remain in contact with both endplate surfaces of adjacent vertebral bodies. In situ bone graft delivery is intended to address the biologic void that can occur between an implant and its two adjacent vertebrae.

Source: Pinnacle Spine Group, LLC

Product Labels: Spinal Fusion

Tags: Regulatory