510(k) K253357

b-ONE® Bipolar Head by B-One Ortho, Corp. — Product Code KWY

K253357 is an FDA 510(k) premarket notification submitted by B-One Ortho, Corp. for the device "b-ONE® Bipolar Head". The FDA issued a decision of Substantially Equivalent on April 13, 2026. The device falls under product code KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented), a Class II device regulated under 21 CFR 888.3390. B-One Ortho, Corp. has at least 10 other 510(k) clearances on record.