# K991882: Nexflex Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Nexmed, Inc.
- Decided: Dec 8, 1999 after 189 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Miller/Gallante Total Knee System (Zimmer, Inc.): named in the summary without a submission number
- (no number) AGC Total Knee System (Biomet, Inc.): named in the summary without a submission number
- (no number) AMK Total Knee System (DePuy, a Johnson & Johnson Company): named in the summary without a submission number
- (no number) Series 7000 Total Knee System (Stryker/Osteonics): named in the summary without a submission number

## Indications for use
Painful, disabling joint disease resulting from rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis Failed osteotomies, unicompartmental replacement, or total knee replacement Post-traumatic loss of knee joint configuration and function Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability The NexFlex Total Knee System is intended for cemented use only.

Source page: https://510kreport.com/device/K991882
Methodology: https://510kreport.com/methodology