Conventus Orthopaedics, with an FDA clearance in hand, plans a gradual rollout of a new device designed to help repair shoulder fractures in a less invasive way.
Conventus said it won 510(k) clearance from the FDA for its Conventus PH, a nitinol device that’s designed to expand inside the bone as an internal scaffold to prevent collapse of a shoulder fracture.
Minneapolis-based Conventus said it’s planning a "measured" U.S. market rollout in the weeks ahead.
Conventus raised a $24 million Series AA round last December that was slated, in part, to commercialize its FDA-cleared Conventus DRS device for distal fractures of the radius, and to propel research and development for the PH device.
The company said it worked with surgeons to develop the device, which helps preserve tissue and blood supply at the fracture, stabilizing bone pieces and helping the patient move sooner through less invasive surgery.
"For years, shoulder surgeons have expressed the need for more versatile surgical options to repair simple to complex proximal humeral fractures," CEO Paul Buckman said in prepared remarks. "The Conventus PH Cage will expand what is possible in patient care by enabling surgeons to repair a wider variety of proximal humeral fractures through less invasive means. We believe this is another important building block in our technology platform and has the potential to transform the repair of shoulder fractures."
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