# K120507: United U2 Femoral Component, PS, #7

- Pathway: 510(k) (Special)
- Applicant: United Orthopedic Corporation
- Decided: May 4, 2012 after 73 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K021657 (2002). 4 ancestors in all.
4 later devices descend from it; 1 cites 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) Summary page 2.
- K972626: Advance Knee System, Wrightmedicaltechnologyinc (1997) Summary page 1.
- K951987: Genesis II Total Knee System, Smith & Nephew Richards, Inc. (1995) Summary page 1.

## Most influential descendants
- K150829: U2 Total Knee System- Additional Sizes (2015), 3 descendants of its own
- K161705: U2 Total Knee System E-XPE products (2017), 1 descendant of its own
- K222700: Tibial baseplate, Tibial insert (2022), 0 descendants of its own
- K210961: U2 Total Knee System, XPE Tibial Insert, PS PLUS (2021), 0 descendants of its own

## Recalls of this device
- Feb 20, 2013 · Class II · Z-1378-2013: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to

## Indications for use
This device 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, posttraumatic 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 can be satisfactorily balanced and stabilized at the time of surgery. This device is intended for cemented use only

Source page: https://510kreport.com/device/K120507
Methodology: https://510kreport.com/methodology