Ignite Orthopedics Gains FDA Clearance for Radial Head Arthroplasty System

By Julie A. Vetalice

Ignite Orthopedics received its first FDA 510(k) clearance, permitting them to market a Radial Head Arthroplasty System to treat fractures and degenerative arthritis in the proximal radius.

When more height is needed for stability, the system accepts in situ addition of a spacer without the need to exchange heads or dislocate the radius and remove the trial. Trials and spacers are radiolucent, allowing the surgeon to assess the spacing of the entire elbow joint when selecting implant size. A Ready-Set Go™ kit contains all implant sizes and sterile single-use instrumentation in one box.

Ignite is a product development and commercialization entity focused on the shoulder and elbow replacement segment of joint reconstruction. Alongside this clearance announcement, the company shared details of a new partnership with a team of upper extremity specialists who will help Ignite develop a complete product portfolio. The surgeons practice in a variety of clinical settings, such as ambulatory surgery centers, outpatient clinics and academic and private institutions, allowing the development of solutions that address a range of clinical issues.

Source: Ignite Orthopedics LLC


Product Labels: Elbow/Radial Head Replacement

Tags: 510(k) Clearance, Regulatory