# K980713: Femoral and Tibial Plugs of Interax Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: May 22, 1998 after 87 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 K973121 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973121: Interax Total Knee System, Howmedica Corp. (1997) Summary page 1.

## Indications for use
The Interax® femoral component and tibial baseplate previously cleared in K 973121 are made available with a PMMA plug inserted onto their central stems. The purpose of this plug is te occlude the internal threaded portion of the central stem of the femoral component and the internal taper surface of the tibial component. The PMMA plug can also be removed to allow the optional use of stem extensions. The current femoral and tibial plugs are fabricated from pellitized PMMA (Simplex P). The new femoral and tibial plugs will be made from a acrylic resin which is supplied by Rohm & Haas. There is no change in the intended use of the femoral and tibial components of the Interax® Total Knee System - The Interax® Total Knee System is intended to be used in cemented primary and/or revision total knee arthroplasty procedures in patients who require total knee replacement as a result of non-inflammatory joint disease and all of its variants, inflammatory joint disease, trauma, or failed previous prosthesis. The Interax® system is intended to accommodate the posterior cruciate ligament if it is intact. The collateral ligaments should be intact, or reparable, or there must be adequate capsular support to provide medio-lateral stability. The Interax® Total Knee System is intended to be implanted using bone cement.

Source page: https://510kreport.com/device/K980713
Methodology: https://510kreport.com/methodology