# K220049: Optimotion Implants Porous Metal-Backed Patella

- Pathway: 510(k) (Traditional)
- Applicant: Optimotion Implants, LLC
- Decided: Mar 14, 2022 after 67 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: 6 generations back to K933785 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132624: Triathlon Tritanium Metal-Backed Patella, Stryker Orthopaedics (2013) Summary page 4.

## Indications for use
The Optimotion Implants Porous Metal-Backed Patella is intended for cemented or cementless applications when resurfacing the surgically prepared patella as part of primary Total Knee Arthroplasty (TKR). The Optimotion Implants Metal-Backed Patella is compatible for use with components of the Optimotion™ Blue Total Knee System components (K191084). General Total Knee Arthroplasty (TKR) Indications: » 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 porous tibial tray and porous CR femoral components are indicated for cemented or cementless use. » Optimotion cemented CR Femoral and cemented tibial tray components are indicated for cemented use only.

Source page: https://510kreport.com/device/K220049
Methodology: https://510kreport.com/methodology