# K060722: Nexgen Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing Articular Surface Component

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: May 26, 2006 after 70 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: 2 generations back to K003910 (2001). 2 ancestors in all.
79 later devices descend from it; 1 cites it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013991: Prolong Highly Crosslinked Polyethtylene Cruciate Retaining (CR) Articular Surface Components, Zimmer, Inc. (2001)

## Most influential descendants
- K081023: Evolis Total Knee System (2008), 78 descendants of its own
- K090988: GMK Total Knee System (2009), 52 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 for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. - Collagen disorders and/or avascular necrosis of the femoral condyle. - Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy - Moderate valgus, varus or flexion deformities. - The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. This device is indicated for use when the posterior cruciate ligament is absent or deficient. This device is intended for use as part of a cemented or uncemented knee prosthesis.

Source page: https://510kreport.com/device/K060722
Methodology: https://510kreport.com/methodology