# K973121: Interax Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Nov 18, 1997 after 90 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: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
25 later devices descend from it; 2 cite it directly.
0 of 26 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) Duracon® Total Knee System: named in the summary without a submission number
- (no number) Kinemax® Plus Total Knee System: named in the summary without a submission number

## Most influential descendants
- K032829: Scorpio Low Profile Tibial Tray (2003), 23 descendants of its own
- K082019: Freedom Total Knee System (2009), 15 descendants of its own
- K091280: Freedom Total Knee Cruciate Retaining (CR) Femoral Component (2009), 7 descendants of its own
- K131481: Freedom PCK Components (2014), 6 descendants of its own
- K071499: Columbus Total Knee System Mios CR/PS Tibial Tray (2007), 6 descendants of its own

## Recalls of this device
- Jan 23, 2003 · Not classified · Z-0854-03: The device is demonstrating early wear and delamination.
- Jan 23, 2003 · Not classified · Z-0855-03: The device is demonstrating early wear and delamination.
- Jan 23, 2003 · Not classified · Z-0856-03: The device is demonstrating early wear and delamination.
- Jan 23, 2003 · Not classified · Z-0858-03: The device is demonstrating early wear and delamination.
- Jan 23, 2003 · Not classified · Z-0851-03: The device is demonstrating early wear and delamination.
- Jan 23, 2003 · Not classified · Z-0857-03: The device is demonstrating early wear and delamination.
- Jan 23, 2003 · Not classified · Z-0853-03: The device is demonstrating early wear and delamination.
- Jan 23, 2003 · Not classified · Z-0852-03: The device is demonstrating early wear and delamination.

## Indications for use
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/K973121
Methodology: https://510kreport.com/methodology