# K150829: U2 Total Knee System- Additional Sizes

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corporation
- Decided: Sep 25, 2015 after 179 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K915132 (1992). 42 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 46 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 4.
- K103733: United U2 Xpe Total Knee System, United Orthopedic Corporation (2011) Summary page 4.
- K120507: United U2 Femoral Component, PS, #7, United Orthopedic Corporation (2012) Summary page 4.
- K131864: U2 Tibial Baseplate- Cma Type, Tibial Insert and Augment, United Orthopedic Corporation (2014) Summary page 4.
- K132752: Ultracongruent Insert, United Orthopedic Corporation (2014) Summary page 4.
- K140073: U2 Femoral Component, CR, Cemented, United Orthopedic Corp. (2014) Summary page 4.

## Most influential descendants
- 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

## 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, 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 a single use implant and intended for cemented use only.

Source page: https://510kreport.com/device/K150829
Methodology: https://510kreport.com/methodology