# K262341: b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions

- Pathway: 510(k) (Traditional)
- Applicant: B-One Ortho, Corp.
- Decided: Sep 8, 2026 after 60 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K180446 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222431: b-ONER MOBIO Total Knee System, B-One Ortho, Corp. (2022) Summary page 5.

## Indications for use
The MOBIO Total Knee System is intended for total knee arthroplasty due to the following conditions: • Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis • Post-traumatic loss of knee joint configuration and function • Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. • Revision of previous unsuccessful knee replacement or other procedure • Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture-management techniques Additional Indications for the Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+) components: • Ligamentous instability requiring implant bearing surface geometries with increased constraint • Absent or nonfunctioning posterior cruciate ligament • Severe anteroposterior instability of the knee joint The MOBIO Total Knee System is intended for implantation with bone cement only. The MOBIO Press-Fit Stem Extensions are intended for cementless applications. MOBIO Total Knee System components are not intended for use with other knee systems.

Source page: https://510kreport.com/device/K262341
Methodology: https://510kreport.com/methodology