www.fdanews.com/articles/188512-fda-clears-b-one-ortho-total-hip-system
FDA Clears b-One Ortho Total Hip System
September 21, 2018
The FDA granted b-One Ortho 510(k) marketing clearance for its total hip system, used in hip replacement surgery.
The cementless device uses advanced coating technology and consists of a bone-conserving femoral prosthesis and a primary acetabular system, compatible with b-One’s 12/14 taper femoral heads.
The company said the system will have a limited U.S. launch in the first half of 2019, followed by a full commercial release later in the year.