# K992462: Osteonics Universal Distal Cement Plug

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Aug 13, 1999 after 21 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
Longest line of descent: 1 generation back to K894708 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914406: PT II Distal Cement Spacer, Osteonics Corp. (1991) Summary page 1.
- K894708: PT Distal Tip Cement Spacer, Osteonics Corp. (1989) Summary page 1.

## Indications for use
The indications for the use of the Osteonics® Universal Distal Hole Plug, in keeping with those of other legally marketed Osteonics accessory products for cemented arthroplasty, are as follows: For cement spacers, mid-shaft restrictors, distal plugs, and cement plugs: In cemented hip arthroplasty, when the cement spacer, restrictor and/or plug is thought to be advantageous.

Source page: https://510kreport.com/device/K992462
Methodology: https://510kreport.com/methodology