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Medicrea’s spinal osteosynthesis rod receives FDA 510(k) approval

France-based Medicrea Group has received 510(k) approval from the US Food and Drug Administration for its spinal osteosynthesis rod, UNiD.

Medicrea

Featuring a user-friendly software tool, UNiD avoids the need to manually contour a rod during surgery, and reduces the amount of time patients spend in the operating room.

Medicrea founder, CEO and chairman Denys Sournac said: "Medicrea’s groundbreaking UNiDTM patient-specific rods include the most current clinical data and software development along with the latest in personalized production and industrialization to revolutionize how spine surgery is performed.

"UNiDTM rods provide surgeons a very precise surgical method, supporting better patient care and improved economic outcomes."

The patient-specific rods are available in two alloys, including Titanium TA6V ELI and Cobalt Chromium, as well as in two diameters, 5.5mm and 6mm.

Medicrea noted that UNiD fits into the Pass LP thoraco-lumbar fixation system, which is already used by multiple spine surgeons in around 35 countries.

The company will showcase the system at the 2014 North American Spine Society (NASS) Annual Meeting, which will be held between 12 and 15 November 2014, in San Francisco, California.

Medicrea also produces the UNiD anterior lumbar interbody fusion (ALIF) spine cages, created with a 3-D printer. It is made of Poly Ether Ketone Ketone (PEKK) and reproduces the anatomic details of a patient’s vertebral endplates.


Image: Medicrea has obtained FDA approval for the spinal osteosynthesis rod UNiD. Photo: courtesy of Business Wire.