Indiana device company receives FDA clearance for elbow system — 3 insights

Spinal Tech

The FDA approved Ignite Orthopedics' radial head arthroplasty system, marking the company's first 510(k) clearance.

What you should know:

1. Physicians can use the radial head system to treat patients with fractures or degenerative arthritis of the proximal radius.

2. Radial head fractures are among the most common types of elbow fractures, according to a study published in the Journal of Shoulder and Elbow Surgery.

3. Ignite also recently partnered with six upper-extremity clinicians to assist with device portfolio expansion efforts.

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