FDA Issues First De Novo Clearance Under Orthopaedic Panel

IlluminOss Medical has received FDA de novo clearance for the IlluminOss Bone Stabilization System, which treats impending and actual pathological fractures of the humerus, radius and ulna resulting from metastatic bone disease. U.S. launch is slated for 2Q18.

This represents FDA's first de novo clearance under the orthopaedic panel. The de novo process provides a pathway to classify novel medical devices for which there is no legally marketed predicate device. De novo classification is a risk-based classification process.

The IlluminOss Bone Stabilization System's first procedure and CE Mark approval occurred in 2009, and it has been commercially available ex-U.S. since 2010. Outcomes data from a 13-site, 80-patient trial supported submission of the company's de novo application to FDA.

The procedure uses a light-curable liquid monomer, contained within an expandable PET balloon catheter, to achieve stabilization. It is performed through a small percutaneous incision. Once the implant is cured and polymerized, it conforms to the geometry of a patient’s intramedullary canal.

Founded in 2007, IlluminOss Medical is headquartered in East Providence, Rhode Island. 

In 2014, we spoke with then-CEO Dirk Kuyper about the technology and IlluminOss’ plan to gain market share. (Kuyper is now President & Owner of Precision Machinists Co. Inc.) “What’s amazing,” said Kuyper, “is that we’re seeing these patients go home in one day vs. four or five days if they had a volar plate, with one week of rehab instead of six…[if] an elderly person loses the use of her hand for five or six weeks, that has a pretty serious impact on her quality of life. The ability to get patients back using their hands almost immediately and to be self-sufficient is a huge improvement in terms of treatment.”