b-ONE Ortho Gains FDA Clearance for Total Hip

By Julie A. Vetalice

b-ONE Ortho received FDA 510(k) clearance to market b-ONE™, a cementless total hip system comprising the Juveno™ Femoral Hip and the b-ONE Primary Acetabular System, compatible with b-ONE 12/14 Taper Femoral Heads.

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.

Source: b-ONE Ortho Corp.

Product Labels: Hip Replacement

Tags: 510(k) Clearance, Regulatory