# K131116: U2 Total Knee System - Psa Type, Offset Stem Adapter

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corporation
- Decided: Oct 30, 2013 after 191 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: 10 generations back to K941847 (1994). 94 ancestors in all.
No later device cites it as a predicate yet.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082424: United U2 Total Knee System, United Orthopedic Corp. (2008) Summary page 1.
- K093293: Vanguard 360 Revision Knee System, Biomet, Inc. (2010) Summary page 1.
- K102437: GMK Revision Knee System, Medacta International S.A. (2010) Summary page 1.

## 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, ostcoarthritis, 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 contraction. This device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require constrained stabilization for tibiofemoral joint due to soft tissue imbalance.

Source page: https://510kreport.com/device/K131116
Methodology: https://510kreport.com/methodology