# K140075: U2 Femoral Component, CR, Porous Coated

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corp.
- Decided: Jun 13, 2014 after 151 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: 2 generations back to K951987 (1995). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051640: U2 Total Knee System, United Orthopedic Corp. (2006)
- K030612: Genesis II Total Knee System, Smith & Nephew, Inc. (2003) Summary page 1.

## Most influential descendants
- K150832: U2 Femoral Component, CR, Porous Coated, Additional Sizes (2015), 2 descendants of its own
- K221705: U2 Total Knee System-PF+ (2023), 1 descendant of its own
- K243656: U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella (2025), 0 descendants of its own

## Indications for use
The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumnatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery. For cemented femoral components, patellar components, tibial baseplate components and tibial inserts components: This device is a single use implant and intended for cemented use only. For porous coated femoral component: This device is a single use implant and intended for cementless use only.

Source page: https://510kreport.com/device/K140075
Methodology: https://510kreport.com/methodology