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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.

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