# K021657: Uknee Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corp.
- Decided: Aug 12, 2002 after 84 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
No predicates in its family tree.
92 later devices descend from it; 4 cite it directly.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Osteonics Omnifit Total Knee System: named in the summary without a submission number
- (no number) Kirschner Performance Total Knee System: named in the summary without a submission number
- (no number) Smith & Nephew Genesis Total Knee System: named in the summary without a submission number

## Most influential descendants
- K090988: GMK Total Knee System (2009), 52 descendants of its own
- K051640: U2 Total Knee System (2006), 38 descendants of its own
- K102437: GMK Revision Knee System (2010), 34 descendants of its own
- K103170: GMK Revision Knee SC Liners (2011), 28 descendants of its own
- K113571: GMK Resufacing Patella Size 4 (2012), 23 descendants of its own

## 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 patello femoral 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/K021657
Methodology: https://510kreport.com/methodology