b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions— 510(k) K262341
Substantially EquivalentB-One Ortho, Corp.
FDA 510(k) clearance K262341 for b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions, Substantially Equivalent on 2026-09-08. Applicant: B-One Ortho, Corp.. Device class: 2.
Summary
B-One Ortho's clearance covers revision components for the b-ONE Mobio Total Knee System: cemented tibial augments, stem extensions, and press-fit stem extensions. Product code JWH is semi-constrained, cemented patellofemorotibial knee prostheses of polymer/metal/polymer construction.
Class II, 21 CFR 888.3560. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k).
B-One Ortho filed from Cedar Knolls, New Jersey. Review took 60 calendar days (July 10 to September 8, 2026).
Clearance details
- Applicant
- B-One Ortho, Corp.
- Product code
- Product code JWH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3560
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cedar Knolls, NJ, US
Recent devices under product code JWH
view allMore clearances from B-One Ortho, Corp.
view allAdverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
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.