# K202429: Mobio Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: B-One Ortho, Corp.
- Decided: Oct 23, 2020 after 59 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K210483: MOBIO Total Knee System (2021), 1 descendant of its own
- K213673: b-ONE MOBIO Total Knee System (2022), 0 descendants of its own

## 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+): ・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/K202429
Methodology: https://510kreport.com/methodology