Meditech Spine received (FDA) 510(k) clearance to market the next generation of its Talos line of interbody devices.
The cervical intervertebral fusion devices are composed of implantable polymer from Invibio Biomaterial Solutions — PEEK-OPTIMA HA Enhanced, which is based on Invibio's PEEK-OPTIMA polymer compounded with hydroxyapatite, an osteoconductive material for enhancing bone apposition.
The Talos devices are designed for use in adult patients with degenerative disc disease of the cervical spine at one level from C2-T1. Invibio supported and provided guidance and data to Meditech Spine for preparation of the 510(k) submission.