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b-ONE Ortho Gains FDA 510(k) Clearance for Total Hip

b-ONE Ortho, a joint reconstruction company, recently gained its first FDA 510(k) clearance for the b-ONE™ cementless total hip. The system comprises the Juveno™ Femoral Hip and the b-ONE Primary Acetabular System, compatible with b-ONE 12/14 Taper Femoral Heads.

The b-ONE hip features stem and shell coatings that include CPTi Plasma Porous Spray, with or without hydroxyapatite, according to the FDA 510(k) summary.

Limited launch will occur in 1H19, followed by full release in 2H19. 

This is the first product for the company, which recently raised US $20.0MM in a Series A financing led by Eight Roads Ventures and F-Prime Capital Partners. Proceeds will support product portfolio growth and expansion into ex-U.S. markets.

b-ONE Ortho was founded in California in 2015. Within 18 months, the company opened a second technology center in New Jersey. In 2016, b-ONE entered the Chinese hip and knee arthroplasty market by acquiring Chinese orthopaedic company Kuan Yue Medical (formerly known as King Charnley).

Earlier this year, b-ONE Ortho hired Mark Kester as Chief Scientific Officer. Kester worked for Stryker for 27 years and is the designer of the Triathlon total knee system. In his role, Kester leads b-ONE’s R&D team to expand its product line.



Julie A. Vetalice, Editorial Assistant and Rob Meyer, Senior Editor, co-authored this report. Reach Rob by
email.

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