Warsaw medical device company lands FDA clearance
By Alex Brown | Inside INdiana Business
A Warsaw-based medical device manufacturer has landed a key approval. Ignite Orthopedics LLC has received FDA clearance to market its Radial Head Arthroplasty System, marking what the company says is a "significant milestone" in its mission.
The FDA clearance is the first for Ignite Orthopedics since its founding in 2017. The company says the Radial Head Arthroplasty System is designed to treat patients who have experienced fracture or degenerative arthritis of the proximal radius in their elbow.
Russ Parrott, vice president of research & development at Ignite, says the radial head arthroplasty market is often underserved.
"There are several clearly reported clinical issues in the literature with existing systems such as implant loosening, overstuffing and dissociation," said Parrott. "Orthopedic surgeons who perform these procedures are in need of new solutions that simplify the most difficult aspects of the surgical procedure and provide more reliable outcomes, which is what this system was designed to address."
In addition to the FDA clearance, Ignite has also announced partnerships with a team of upper extremity specialists who have aligned with the company to develop a complete should and elbow arthroplasty portfolio. You can view the full list of the specialists involved in the surgeon development team by clicking here.