# K213673: b-ONE MOBIO Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: B-One Ortho, Corp.
- Decided: Jan 21, 2022 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 K202429 (2020). 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)
- K202429: Mobio Total Knee System, B-One Ortho, Corp. (2020) Summary page 4.
- K210483: MOBIO Total Knee System, B-One Ortho, Corp. (2021) Summary page 4.

## 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 PS and PS+: · 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. MOBIO Total Knee System components are not intended for use with other knee systems.

Source page: https://510kreport.com/device/K213673
Methodology: https://510kreport.com/methodology