# K051640: U2 Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corp.
- Decided: Mar 1, 2006 after 254 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: 1 generation back to K021657 (2002). 1 ancestor in all.
38 later devices descend from it; 16 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021657: Uknee Total Knee System, United Orthopedic Corp. (2002) Summary page 1.

## Most influential descendants
- K082424: United U2 Total Knee System (2008), 15 descendants of its own
- K123339: TK1 Total Knee System (2013), 11 descendants of its own
- K142649: Progressive Orthopedic Total Knee System (2015), 10 descendants of its own
- K131398: Novoknee Total Knee System (2013), 10 descendants of its own
- K122183: Augment and Screw, Psa Type (2013), 10 descendants of its own

## Recalls of this device
- Nov 24, 2017 · Class II · Z-1128-2018: UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling.

## 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 system is designed for cemented use only.

Source page: https://510kreport.com/device/K051640
Methodology: https://510kreport.com/methodology