# K965056: Osteonics Screw Hole Plugs

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Feb 28, 1997 after 72 days
- Product code: JDK (Prosthesis, Hip, Cement Restrictor)
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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® UHMWPE Acetabular Shell Cement Spacer System: named in the summary without a submission number
- (no number) Osteonics® Acetabular 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

## Indications for use
The Osteonics® Screw Hole Plugs are intended to occlude the unused dome screw holes of any Osteonics acetabular shell component. The Osteonics® Screw Hole Plugs will be used either with or without bone cement depending upon the labeled indications of the associated acetabular shell component. The Osteonics® Screw Hole Plugs do not carry their own indications and contraindications, but-- as accessories to acetabular shell components-- would be subject to all of the indications and contraindications of the associated acetabular shells.

Source page: https://510kreport.com/device/K965056
Methodology: https://510kreport.com/methodology