Implanet has received 510(k) regulatory clearance from the US Food and Drug Administration (FDA) removing the intended use of the Jazz Band platform with the Implanet Spine System. Jazz may be used with other posterior thoracolumbar fixation systems (screws, rods, hooks) available on the market.
Ludovic Lastennet, chief executive officer of Implanet, says: “We had been eagerly awaiting this latest clearance, which represents a major milestone in our development. Surgeons may now utilise 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 multicentre prospective studies in the USA. It sends a strong signal less than a month from the start of major spine surgery conferences, the Scoliosis Research Society and North American Spinal Society 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.”
This latest FDA clearance follows that obtained in June for the expanded Jazz Band range, allowing the company to respond to all surgeon requests through the offer of a comprehensive range covering various diameters.