b-ONE® Bipolar Head— 510(k) K253357
Substantially EquivalentB-One Ortho, Corp.
FDA 510(k) clearance K253357 for b-ONE® Bipolar Head, Substantially Equivalent on 2026-04-13. Applicant: B-One Ortho, Corp.. Device class: 2.
Summary
B-One Ortho's b-ONE Bipolar Head is filed under product code KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented).
Class II, 21 CFR 888.3390. It came in as a Traditional 510(k), and Orthopedic is both the classification panel and the review panel.
B-One Ortho filed from Cedar Knolls, New Jersey. Review took 195 calendar days (September 30, 2025 to April 13, 2026).
Clearance details
- Applicant
- B-One Ortho, Corp.
- Product code
- Product code KWY
- Device class
- Class 2
- Regulation
- 21 CFR 888.3390
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cedar Knolls, NJ, US
Recent devices under product code KWY
view allMore clearances from B-One Ortho, Corp.
view all- K262341 — b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions
- K240528 — b-ONE® Total Hip System
- K222431 — b-ONER MOBIO Total Knee System
- K213673 — b-ONE MOBIO Total Knee System
- K212912 — OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System
Adverse events under product code KWY
product code KWY- Death
- 3
- Injury
- 2,049
- Total
- 2,052
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.