Early stage orthopedic tech company B-One Ortho said today it won FDA 510(k) clearance for the B-One total hip system, touting it as its first device clearance from the agency.
The B-One is a cementless total hip system which features coating technology and instrumentation intended to optimize patient fit for a modern patient demographic, the Cedar Knolls, N.J.-based company said.
The system includes the Juveno bone-conserving femoral prosthesis and the B-One primary acetabular systems, which the company said are compatible with the B-One 12/14 taper femoral heads.
B-One said that it is planning for a limited launch of the system during the first half of next year and a full commercial release during the second half of next year.
“This milestone for the company will officially introduce B-One’s product line to the U.S. market. With our first US 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,” chief scientific officer Dr. Mark Kester said in a press release.
\The company said it recently raised $20 million in a Series A round of financing led by Eight Roads Ventures and F-Prime Capital Partners, with proceeds slated to fund product portfolio growth and expansion into international markets.