# K982585: Depuy Amk Total Knee System Depuy Coordinate Ultra Knee Revision System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Oct 5, 1998 after 73 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 K864671 (1987). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864671: Anatomic Modular Knee (Amk) System, Depuy, Inc. (1987) Summary page 1.
- K910940: Anatomic Modular Knee Polyethylene Tibial Tray, Depuy, Inc. (1991) Summary page 1.
- K943299: Depuy Amk All Polyethylene Posterior Stablilized Tibial Tray, Depuy, Inc. (1995) Summary page 1.
- K954684: Depuy Anatomic Modular Knee (Amk) Congruency Posterior Stabilized Tibial Insert, Depuy, Inc. (1996) Summary page 1.
- K955884: Coordinate Revision Knee System, Depuy, Inc. (1996) Summary page 1.
- K972596: Depuy Duraloc Acetabular Cup System, Depuy, Inc. (1997) Summary page 1.

## Indications for use
The DePuy AMK and Coordinate Ultra Cross-Linked Polyethylene Inserts and Trays are to be used with the currently marketed AMK Total Knee System and/or the Coordinate Ultra Knee Revision System components. The DePuy AMK Total Knee System and Coordinate Ultra Knee Revision System are intended to be used in cemented tricompartmental total knee arthroplasty to replace severely disabled or painful joints resulting from osteoarthritis or post-traumatic arthritis, joints with correctable varus or valgus deformity, and joints with failed previous surgeries where pain, deformity or dysfunction persist.

Source page: https://510kreport.com/device/K982585
Methodology: https://510kreport.com/methodology