The Food & Drug Administration cleared Aesculap Implant Systems LLC’s S4 cervical occipital plating system.
The Center Valley, Pa.-based company received a "substantial equivalence" determination for its Special 510(k) application for the spinal injury treatment system seven months after the FDA began its review of the device, according to the company.
A medical device is eligible for a Special 510(k) if the device was only modified from a previous version and the new changes do not affect the intended use or alter the fundamental scientific technology of the device, according to the FDA.
Aesculap‘s S4 device is intended to promote spinal fusion of the cervical and thoracic spine — vertebrae C1 through T3 — and the occipito-cervico-thoracic junction — the occiput through vertebra T3 — in patients with degenerative disease or fracture, according to the company.
The agency also recently granted the company traditional 510(k)‘s for its SIBD spinal system and Vega knee system.