# K180446: b-ONE Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: B-One Ortho, Corp.
- Decided: Oct 12, 2018 after 234 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; 1 cites 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K061383: Bti Sterile Dental Drills Kit, Bti Abutments and Caps, B.T.I. Biotechnology Institute, Sl. (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K222431: b-ONER MOBIO Total Knee System (2022), 1 descendant of its own
- K262341: b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K180446
Methodology: https://510kreport.com/methodology