French orthopedic implant company Implanet said Wednesday it won expanded FDA 510(k) clearance for its Jazz spinal implant allowing it to be used with other posterior thoraco-lumbar fixation systems.
The Jazz implant is intended to provide temporary stabilization as a bone anchor during bone fusions and to aid in the repair of bone fractures. The device is cleared for spinal trauma surgeries, spinal reconstructive surgeries and spinal degenerative surgeries, according to its website.
“We had been eagerly awaiting this latest clearance, which represents a major milestone in our development. Surgeons may now utilize their posterior fixation system of choice when incorporating Jazz into their hybrid constructs. On a clinical level, this clearance will also allow us to initiate extensive multi-center prospective studies in the United States. It sends a strong signal less than a month from the start of major spine surgery conferences, the SRS and NASS annual meetings, and we are confident that this latest clearance will enable us to accelerate our technology’s regulatory process in other countries with substantial market potential,” CEO Ludovic Lastennet said in prepared remarks.
Implanet obtained its previous 510(k) clearance for the Jazz band devices, and has received CE Mark approval in the European Union.
