| K-number | K253357 |
| Device name | b-ONE® Bipolar Head |
| Applicant | B-One Ortho, Corp. |
| Product code | KWY |
| Device class | Class II |
| Decision date | Apr 13, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3390 |
The b-ONE® Bipolar Head is a hemi-hip prosthesis component consisting of a cobalt-chromium shell with ultrahigh-molecular-weight polyethylene (UHMWPE) liner and retaining ring. It is intended for hemi-hip arthroplasty in patients with a satisfactory natural acetabulum and sufficient femoral bone, for conditions including acute femoral head/neck fractures, fracture dislocations, avascular necrosis, non-union of femoral neck fractures, certain elderly fractures, and degenerative arthritis limited to the femoral head.
The device shares materials of construction (CoCr ASTM F75 shell, UHMWPE ASTM F648 liner and retaining ring), size range (40-65 mm, 26 sizes), shape similarity, and sterilization methods with predicate devices. The bipolar design provides primary articulation between femoral head and polyethylene liner, and secondary articulation between outer shell and patient's acetabulum. It is compatible with b-ONE CoCr and ceramic heads of 28 mm size.
ISO 21535 (Range of Motion Testing), ASTM F2582 (Impingement Testing), ISO 10993-1 (Biocompatibility Assessment), USP <85> (Endotoxin Testing), and material characterization, wear testing assessment, and pull-off/lever-off disassembly testing.
View the full FDA submission: accessdata.fda.gov