# K240938: The Optimotion™ Blue Plus Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Optimotion Implants, LLC
- Decided: Jun 27, 2024 after 83 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K933785 (1995). 55 ancestors in all.
No later device cites it as a predicate yet.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141056: Triathlon Knee System Posterior Stabilized Components, Stryker Orthopaedics (2014) Summary page 4.
- K191084: The Optimotion Blue Total Knee System, Optimotion Implants, LLC (2020) Summary page 4.

## Indications for use
• 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 configurations 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. • Ligamentous instability requiring implant bearing surface geometries with increased constraint. • Absent or non-functioning posterior cruciate ligament. • Severe anteroposterior instability of the knee joint • Optimotion™ Blue Plus Knee System and Optimotion™ Blue Total Knee System non-porous implant components are indicated for cemented use only. • Optimotion™ Blue Plus Knee System and Optimotion™ Blue Total Knee System porous coated implant components are indicated for cemented or uncemented use.

Source page: https://510kreport.com/device/K240938
Methodology: https://510kreport.com/methodology