# K961379: Depuy Amk Porous Coated CRX Tibial Tray (1988-20/28-000 and 1988-20/28-501)

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Jun 18, 1996 after 69 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 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) DePuy AMK Cemented CRX Tibial Tray: named in the summary without a submission number
- (no number) DePuy Synatomic Variable Fit Tibial Plateau: named in the summary without a submission number
- (no number) Howmedica PCA Modular Stemmed Tibial Baseplate: named in the summary without a submission number

## Most influential descendants
- K991106: P.F.C. Sigma Porous Modular Keel Tibial Tray (1999), 3 descendants of its own
- K182301: PFC SIGMA Knee System (2019), 1 descendant of its own
- K200765: Genius / Genuin Total Knee System (2021), 0 descendants of its own
- K003026: PFC Sigma Lugged Tibial Tray (2001), 0 descendants of its own

## Indications for use
The DePuy AMK Porous Coated CRX Tibial Tray is intended to be used as the tibial component in cemented total knee arthroplasty.

Source page: https://510kreport.com/device/K961379
Methodology: https://510kreport.com/methodology