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FDA Clears Ortho Development’s New Hip Stem

The device is made for cementless use in THAs.

Draper, Utah-based Ortho Development Corporation has earned 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Ovation Tribute hip stem. The Ovation Tribute is a femoral hip prosthesis that is intended for cementless use in total hip replacement and hemiarthroplasty procedures.

Building off the clinical success of Ortho Development’s Ovation hip stem, the Ovation Tribute incorporates new design features that better accommodate multiple surgical approaches including the direct anterior approach. The Ovation Tribute is a tapered wedge, short stem provided in 12 sizes with standard and extended neck offsets to anatomically accommodate a variety of patients. The proximal region of the stem is coated with titanium plasma spray to provide solid, long-term fixation while the optimized neck geometry of the stem allows for improved range of motion.

The Ovation Tribute is the latest addition to Ortho Development’s hip product line and is designed for use with Ortho Development’s femoral heads and compatible acetabular components. The Ovation Tribute includes a minimal broach-only instrumentation platform.

Ortho Development currently markets its products through a network of independent sales representatives and distributors in the United States and through Japan Medical Dynamic Marketing Inc. in Japan.

Ortho Development makes devices for knee and hip joint reconstruction, spine treatment, and trauma fracture repair.

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