b-ONE® Bipolar Head
FDA 510(k) K253357 · B-One Ortho, Corp.
510(k) numberK253357
Submission
- Device name
- b-ONE® Bipolar Head
- Applicant
- B-One Ortho, Corp.
Cedar Knolls, NJ, US - Received
- September 30, 2025
- Decision date
- April 13, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3390
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243634 | Maxx Libertas Bipolar Hip Head (Bipolar Hip)KWY · Traditional | Maxx Orthopedics, Inc. | 08/25/2025SE |
| K231526 | CORAIL Cemented Femoral StemKWY · Traditional | Depuy Ireland UC | 12/19/2023SE |
| K223441 | SpaceFlex Acetabular CupKWY · Traditional | G21, S.R.L. | 03/23/2023SE |
| K221794 | Vario-Cup SystemKWY · Special | Waldemar Link GmbH & Co. KG | 07/20/2022SE |
| K220492 | COPAL exchange G hip spacerKWY · Special | Heraeus Medical GmbH | 03/23/2022SE |
| K200709 | Kyocera Bipolar Hip SystemKWY · Special | Kyocera Medical Technologies, Inc. | 04/17/2020SE |
| K192236 | Fitmore Hip StemKWY · Special | Zimmer GmbH | 11/05/2019SE |
| K191016 | COPAL exchange G Hip and Knee SpacersKWY · Traditional | Heraeus Medical GmbH | 11/01/2019SE |
| K191297 | iNSitu Bipolar Hip SystemKWY · Traditional | Theken Companies, LLC | 09/17/2019SE |
| K191569 | Implantcast ic-Bipolar Head SystemKWY · Traditional | Implantcast GmbH | 08/28/2019SE |
More from Implantcast GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K262341 | b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and…JWH · Traditional | 09/08/2026SE |
| K240528 | b-ONE® Total Hip SystemLZO · Traditional | 11/15/2024SE |
| K222431 | b-ONER MOBIO Total Knee SystemJWH · Traditional | 10/06/2022SE |
| K213673 | b-ONE MOBIO Total Knee SystemJWH · Traditional | 01/21/2022SE |
| K212912 | OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…MAI · Traditional | 11/04/2021SE |
| K210483 | MOBIO Total Knee SystemJWH · Traditional | 04/21/2021SE |
| K202768 | KOSMO Femoral StemLZO · Traditional | 04/01/2021SE |
| K202429 | Mobio Total Knee SystemJWH · Traditional | 10/23/2020SE |
| K182705 | Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System CupsLZO · Traditional | 02/14/2019SE |
| K183025 | MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total…JWH · Traditional | 01/28/2019SE |
Questions and answers
When was b-ONE® Bipolar Head cleared by the FDA?
b-ONE® Bipolar Head (K253357) received a 510(k) decision of Substantially Equivalent on April 13, 2026, 195 days after the submission was received.
What is the product code of K253357?
The FDA product code is KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3390.