b-ONE Ortho Corp., an emerging orthopedic technology company dedicated to the development of innovative healthcare solutions, today announced it has received 510(k) clearance for its first device, the b-ONETM Total Hip System, from the U.S. Food and Drug Administration (FDA).
The b-ONETM Total Hip System is a cementless total hip system with advanced coating technology and intuitive instrumentation, designed to optimize patient fit in the modern patient demographic. The system comprises the JuvenoTM Femoral Hip, a bone-conserving femoral prosthesis, and the b-ONE Primary Acetabular System, which are compatible with b-ONETM 12/14 Taper Femoral Heads.
“This milestone for the company will officially introduce b-ONE’s product line to the U.S. market,” said Dr. Mark Kester, the Chief Scientific Officer. “With our first U.S. surgery quickly approaching, we are eager to provide surgeons with a versatile system designed to accommodate the majority of today’s expanding patient demographic. In addition, with the support of Dr. Richard Rothman, a prolific designer and developer in the orthopedic industry, our strong R&D team will continue the development and expansion of our product portfolio with a focus on quality, affordability and speed to market.”
The b-ONETM Total Hip System will have a limited launch in the first half of 2019, followed by a full commercial release in the second half of 2019.
This news follows b-ONE Ortho Corp.’s recent US$20 million Series A financing led by Eight Roads Ventures and F-Prime Capital Partners. Proceeds are being used to fund the growth of b-ONE Ortho Corp.’s product portfolio and expansion into international markets.