Data / Medical devices / United States / b-ONE Ortho Corp.
b-ONE Ortho Corp.: FDA-registered device maker in Fairfield, NJ, United States, 11 510(k) clearances
b-ONE Ortho Corp. is registered with the FDA (registration 3042508254) in Fairfield, NJ, United States. It lists 24 device types. The FDA files 11 510(k) clearances under its listings, the newest dated April 13, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042508254
- Address
- 159 Dwight Pl, Fairfield, NJ, United States, 07004
- Owner or operator
- b-ONE Ortho, Corp. (10059458)
- Roles
- Specification developer
- First device listed
- January 28, 2019
- Registered through
- 2026
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 13, 2026 | K253357 | b-ONE® Bipolar Head | KWY | Substantially Equivalent | B-One Ortho, Corp. | accessdata.fda.gov |
| November 15, 2024 | K240528 | b-ONE® Total Hip System | LZO | Substantially Equivalent | B-One Ortho, Corp. | accessdata.fda.gov |
| October 6, 2022 | K222431 | b-ONER MOBIO Total Knee System | JWH | Substantially Equivalent | B-One Ortho, Corp. | accessdata.fda.gov |
| January 21, 2022 | K213673 | b-ONE MOBIO Total Knee System | JWH | Substantially Equivalent | B-One Ortho, Corp. | accessdata.fda.gov |
| April 21, 2021 | K210483 | MOBIO Total Knee System | JWH | Substantially Equivalent | B-One Ortho, Corp. | accessdata.fda.gov |
| April 1, 2021 | K202768 | KOSMO Femoral Stem | LZO | Substantially Equivalent | B-One Ortho, Corp. | accessdata.fda.gov |
| October 23, 2020 | K202429 | Mobio Total Knee System | JWH | Substantially Equivalent | B-One Ortho, Corp. | accessdata.fda.gov |
| February 14, 2019 | K182705 | Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups | LZO | Substantially Equivalent | B-One Ortho, Corp. | accessdata.fda.gov |
| January 28, 2019 | K183025 | MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component | JWH | Substantially Equivalent | B-One Ortho, Corp. | accessdata.fda.gov |
| October 12, 2018 | K180446 | b-ONE Total Knee System | JWH | Substantially Equivalent | B-One Ortho, Corp. | accessdata.fda.gov |
| August 30, 2018 | K173380 | b-ONE® Total Hip System | LZO | Substantially Equivalent | B-One Ortho, Corp. | accessdata.fda.gov |
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Updated April 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.