510(k) · Cleared
ClearedOsteonics Universal Distal Cement Plug
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · LZN Cement Obturator
Cleared on Aug 13, 1999 as substantially equivalent to K914406 (Osteonics Corp., 1991) and 1 other predicate after a 21-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Aug 13, 1999
- Review
- 21 days
- Class
- Class II
- Product code
- LZN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K894708 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK894708 PT Distal Tip Cement SpacerOsteonics Corp. · 1989
- This deviceK992462 Osteonics Universal Distal Cement PlugHowmedica Osteonics Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894708 | PT Distal Tip Cement Spacer | Osteonics Corp. | 1989 | — |
| 0 (this device) | K992462 | Osteonics Universal Distal Cement Plug | Howmedica Osteonics Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LZN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LZN device
- #1 K220838 Artisan Bone Plug, Universal Cement Restrictorscore 11.8 · 9 generations · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K914406 | PT II Distal Cement SpacerSummary page 1…he following Howmedica Osteonics predicate devices, which has been cleared for marketing via the 510(k) process: ® Osteonics® Omnifit® Universal Distal Cement Spacer (K914406) ® Osteonics® Universal Distal Spacer (K894708) Device Description The Osteonics® Universal Distal Hole Plug is a single use c… | 1991 |
| * | K894708 | PT Distal Tip Cement SpacerSummary page 1…es, which has been cleared for marketing via the 510(k) process: ® Osteonics® Omnifit® Universal Distal Cement Spacer (K914406) ® Osteonics® Universal Distal Spacer (K894708) Device Description The Osteonics® Universal Distal Hole Plug is a single use component which is intended for optional use in c… | 1989 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K914406.
How does its category compare?
All LZN devicesLZN Cement Obturator: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZN
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LZN
Too few LZN 510(k)s in any year since 2007 to give a median.
Recalls per year · LZN
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZN
6in 2025
MAUDE reports naming product code LZN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 13 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 30 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 1 | — | 1 | 6 |
| 2023 | 0 | — | 0 | 13 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992462 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992462: Osteonics Universal Distal Cement Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992462
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026