FDA OKs Conventus Orthopaedics’ Shoulder Fracture Cage
Conventus Orthopaedics’ PH Cage for shoulder fracture surgical repair — the first expandable shoulder fracture cage — has won FDA 510(k) clearance, the Maple Grove, Minn., devicemaker announced Tuesday.
The nickel titanium alloy device expands within the bone and prevents further fracture collapse. The PH Cage’s rigid internal scaffold is similar to the company’s first product, the Distal Radius Surgical System for wrist fixation. That device received FDA clearance in 2013.
Previously, patients who needed surgery for multipart fractures of the shoulder’s proximal humerus had to undergo invasive fixation procedures or, in severe cases, shoulder replacement operations, the company says.
The devicemaker is planning a limited U.S. launch within the next few weeks. — Jason Scott