# K191084: The Optimotion Blue Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Optimotion Implants, LLC
- Decided: Apr 7, 2020 after 349 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: 8 generations back to K933785 (1995). 37 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160515: PS2 Knee System, Consensus Orthopedics, Inc. (2016) Summary page 4.
- K123486: Triathlon Tritanium Tibial Baseplate, Stryker (2013) Summary page 4.
- K051380: Triathlon Press-Fit Total Knee System, Howmedica Osteonics Corp. (2005) Summary page 4.

## Most influential descendants
- K240938: The Optimotion™ Blue Plus Knee System (2024), 0 descendants of its own

## 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. Optimotion™ Blue Porous Tibial Baseplate components are indicated for Cemented or Cementless use. The Optimotion™ Blue Porous CR Femoral components are indicated for Cemented or Cementless use. The Optimotion™ Blue CEMENTED CR Femoral and CEMENTED Tibial Baseplate components are indicated for cemented use only.

Source page: https://510kreport.com/device/K191084
Methodology: https://510kreport.com/methodology