# K032479: Howmedica Osteonics Tibial Tray Screw Hole Plugs

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Sep 4, 2003 after 23 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 K970779 (1997). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970779: Osteonics Tibial Tray Screw Hole Plugs, Osteonics Corp. (1997) Summary page 1.

## Most influential descendants
- K053390: Columbus (CR) Total Knee System (2006), 5 descendants of its own
- K120955: Columbus Total Knee System as Columbus Revision Knee System Enduro Knee System (2012), 4 descendants of its own
- K143443: VEGA Knee System, Columbus Total Knee System (2015), 3 descendants of its own
- K191765: OMNI TiN Coated Apex Knee™ System (2019), 2 descendants of its own
- K252044: Triathlon® Total Knee System - Triathlon® Gold Femoral Components (2025), 0 descendants of its own

## Indications for use
The subject Tibial Tray Screw Hole Plugs are intended to occlude all tibial tray screw holes not occupied by bone screws. The Tibial Tray Screw Hole Plugs are factory assembled to the tibial tray screw holes. Intraoperatively, the surgeon will remove the plugs from whichever screw holes will be filled with a bone screw. By occluding the tibial tray screw holes, the Tibial Tray Screw Hole Plugs help prevent intrusion of bone cement onto the tibial tray.

Source page: https://510kreport.com/device/K032479
Methodology: https://510kreport.com/methodology