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b-ONE Ortho Corp., an emerging orthopedic technology company dedicated to the development of innovative healthcare solutions, 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.
About b-ONE Ortho Corp.
Based in Cedar Knolls, New Jersey, b-ONE Ortho Corp. is an emerging orthopedic technology company dedicated to the development of innovative orthopedic healthcare solutions that restore patient mobility and improve surgical outcomes. Every day we are committed to becoming the most credible choice for orthopedic products worldwide.
For Further Information
More on the orthopedic large joints replacement market in the U.S. can be found in a series of reports published by iData entitled the U.S. Market Report Suite for Orthopedic Large Joint Devices. This report covers the following market segments: hip implants, knee implants, and bone cement.
The iData series on the market for orthopedic large joint devices covers the U.S., India, Japan, China, and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about orthopedics large joint replacement market data or procedure data, register online or email us at [email protected] for an U.S. Market Report Suite for Orthopedic Large Joint Devices brochure and synopsis.