# K970779: Osteonics Tibial Tray Screw Hole Plugs

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: May 9, 1997 after 66 days
- Product code: LZN (Cement Obturator)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites 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)
- None. The FDA summary names its predicate without a number.
- (no number) Osteonics® Omnifit® Total Knee System Screw Hole Plugs: named in the summary without a submission number
- (no number) Osteonics® Universal Cement Plug: named in the summary without a submission number

## Most influential descendants
- K032479: Howmedica Osteonics Tibial Tray Screw Hole Plugs (2003), 7 descendants of its own
- 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

## Indications for use
The Osteonics® Tibial Tray Screw Hole Plugs are intended to occlude the unused tibial screw holes of any Osteonics tibial tray component. The Osteonics® Tibial Tray Screw Hole Plugs will be used with bone cement. The Osteonics® Tibial Tray Screw Hole Plugs do not carry their own indications and contraindications, but-- as accessories to tibial tray components-- would be subject to all of the indications and contraindications of the associated tibial trays.

Source page: https://510kreport.com/device/K970779
Methodology: https://510kreport.com/methodology