RegulatorySpine

FDA CLEARS FIRST PATIENT-SPECIFIC SPINAL ROD

Walter Eisner • Thu, November 13th, 2014

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The French-based Medicrea Group says it has received FDA 510(k) clearance for its UNiD spinal device, which according to the company, is the world’s first patient-specific spinal osteosynthesis rod to treat degenerative spine conditions including scoliosis.

The technology was introduced at the 2014 North American Spine Society (NASS) Annual Meeting on November 12, 2014 in San Francisco, California. The first U.S. patient underwent surgery to have personalized UNiD rods implanted on November 10, 2014 in New York. The surgery was performed by Frank J. Schwab, M.D. The system has been implanted in over 100 patients in Europe.

UNiD Features

The system, according to the company, features a “user-friendly software tool to help surgeons preoperatively plan their surgery and order customized, industrially-produced rods to fit the specific spinal alignment needed for each individual patient.” The company says the device reduces the amount of time a patient spends in the operating room because there is no need to manually contour a rod during surgery. The surgeon is provided with a “precisely aligned” rod prior to surgery. Less time in the operating room impacts infections rates and quality of recovery.

Until now, surgeons have had to use a bending device, known as a French bender, supplied in all instrument kits to bend the rods manually. This manual rod-contouring process involves estimating the curve in a very empirical manner using pre-operative X-rays displayed on a wall in the operating room.

“Improved” Economic Outcomes

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Josh Sandberg

Josh Sandberg is the President of Ortho Sales Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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