# K013991: Prolong Highly Crosslinked Polyethtylene Cruciate Retaining (CR) Articular Surface Components

- Pathway: 510(k) (Special)
- Applicant: Zimmer, Inc.
- Decided: Dec 27, 2001 after 23 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: 1 generation back to K003910 (2001). 1 ancestor in all.
203 later devices descend from it; 4 cite it directly.
0 of 205 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003910: Nexgen Complete Knee Solution Cross-Linked Polyethylene Cruciate Retaining (CR) Articular Surface Components, Zimmer, Inc. (2001) Summary page 1.

## Most influential descendants
- K070214: Gender Solutions Natural-Knee Flex System (2007), 123 descendants of its own
- K073286: Gender Solutions Natural-Knee Flex System (2008), 117 descendants of its own
- K113369: Zimmer Persona Knee System (2012), 96 descendants of its own
- K060722: Nexgen Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing Articular Surface Component (2006), 79 descendants of its own
- K081023: Evolis Total Knee System (2008), 78 descendants of its own

## Indications for use
This device is intended to reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for 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, posttrawmatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellcctomy, 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. Prolong crosslinked polyethylene cruciate retaining articular surfaces are intended to be used as part of a cemented knee system.

Source page: https://510kreport.com/device/K013991
Methodology: https://510kreport.com/methodology