510(k) clearance
b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions
- 510(k) number
- K262341
- Applicant
- B-One Ortho, Corp.
- Decision date
- Sep 8, 2026
- Date received
- Jul 10, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- JWH
- Device type
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class II
- Regulation
- 21 CFR 888.3560
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Cedar Knolls, NJ, US