FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Ignite Orthopedics’ Radial Head Arthroplasty System Cleared

June 5, 2019
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Ignite Orthopedics has received 510(k) clearance for its Radial Head Arthroplasty System, the firm’s first product to receive FDA clearance.

The company’s Radial Head Arthroplasty System is designed to treat patients with fractured or degenerative arthritis of the proximal radius. Radial head fractures account for approximately one-third of all elbow fractures.

The system allows a spacer to be placed when joint stability requires added height. A surgeon can insert the spacer without having to dislocate the radius, which can disrupt the surrounding soft tissue and slow down surgery.

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