# K183025: MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component

- Pathway: 510(k) (Traditional)
- Applicant: B-One Ortho, Corp.
- Decided: Jan 28, 2019 after 88 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K114464: Zimmer Persona The Personalized Knee System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The b-ONE® 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 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 b-ONE® MOBIO® Total Knee System is intended for implantation with bone cement only. b-ONE® MOBIO® Total Knee System components are not intended for use with other knee systems.

Source page: https://510kreport.com/device/K183025
Methodology: https://510kreport.com/methodology