510(k) Report

510(k) · Cleared

Cleared

Osteonics Tibial Tray Screw Hole Plugs

K970779510(k) TraditionalCleared May 9, 199766-day reviewClass II21 CFR 878.3300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Osteonics Corp. · LZN Cement Obturator

Cleared on May 9, 1997 after a 66-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.

Decided
May 9, 1997
Review
66 days
Class
Class II
Product code
LZN
Recalls
None
Predicates
0

8 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2010: 1 descendant cleared2006: 1 descendant cleared2012: 1 descendant cleared2015: 1 descendant cleared2019: 1 descendant cleared2021: 1 descendant cleared2025: 1 descendant cleared1995200020052010201520202025
  1. This deviceK970779 Osteonics Tibial Tray Screw Hole PlugsOsteonics Corp. · 1997
  2. Descendant · cites it directly · 7 of its ownK032479 Howmedica Osteonics Tibial Tray Screw Hole PlugsHowmedica Osteonics Corp. · 2003
  3. Descendant · 2 generations on · 5 of its ownK053390 Columbus (CR) Total Knee SystemAesculap, Inc. · 2006 · Recalled
  4. Descendant · 3 generations on · 4 of its ownK120955 Columbus Total Knee System as Columbus Revision Knee System Enduro…Aesculap Implant Systems, LLC · 2012
  5. Descendant · 3 generations on · 3 of its ownK143443 VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC · 2015
  6. Descendant · 4 generations on · 2 of its ownK191765 OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2003: 12006: 12010: 12012: 12015: 12019: 12021: 12025: 1
2003high 1 (2003) · low 0 (2004)2026

Most influential descendants

Showing 5 of 8 · See all
  • K032479Howmedica Osteonics Tibial Tray Screw Hole PlugsHowmedica Osteonics Corp. · 2003 · cites it directly7descendants
  • K053390Columbus (CR) Total Knee SystemAesculap, Inc. · 2006 · 2 generations on5descendants
  • K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC · 2012 · 3 generations on4descendants
  • K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC · 2015 · 3 generations on3descendants
  • K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K970779Osteonics Tibial Tray Screw Hole PlugsOsteonics Corp.1997—
+1K032479Howmedica Osteonics Tibial Tray Screw Hole PlugsHowmedica Osteonics Corp.2003—
+2K053390Columbus (CR) Total Knee SystemAesculap, Inc.20061
+3K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC2012—
+3K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC2015—
+4K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200610
201010
201210
201510
201910
202110
202510
FIG. 1 — Lineage of K970779, 1997–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K220838 Artisan Bone Plug, Universal Cement Restrictorscore 11.8 · 9 generations · no Class I recall
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*—Osteonics® Omnifit® Total Knee System Screw Hole Plugs
Named without a submission number
—
*—Osteonics® Universal Cement Plug
Named without a submission number
—

What descends from it? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032479Howmedica Osteonics Tibial Tray Screw Hole PlugsHowmedica Osteonics Corp.20037

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?

  • Of its descendants, K032479 (Howmedica Osteonics Corp., 2003) has gone furthest, with 7 descendants of its own.

How does its category compare?

All LZN devices

LZN Cement Obturator: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZN

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

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

2022: 1
2007high 1 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZN

6in 2025

2007: 12008: 22009: 32010: 72011: 32012: 132013: 42014: 302015: 412016: 62017: 62018: 82019: 112020: 112021: 122022: 62023: 132024: 72025: 6
2007high 41 (2015) · low 1 (2007)2025

MAUDE reports naming product code LZN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—02
20090—03
20100—07
20110—03
20120—013
20130—04
20140—030
20150—041
20160—06
20170—06
20180—08
20190—011
20200—011
20210—012
20221—16
20230—013
20240—07
20250—06
20260—0—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Osteonics Corp.

178 FDA decisions under this applicant name. See the company

  • K983657Osteonics Series 7000 AD Tibial TrayOsteonics Corp. · 2000
  • K980070Osteonics HA-Coated DevicesOsteonics Corp. · 1999
  • K984375Osteonics Spinal System - Sacral Offset Connector AssemblyOsteonics Corp. · 1999
  • K982798Osteonics Anterior Cervical Compression Plating SystemOsteonics Corp. · 1999
  • K984585Osteonics +10 Unipolar Adaptor SleeveOsteonics Corp. · 1999

Recent decisions in LZN

The LZN category page

  • K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics · 2022
  • K061824Tornier Cement RestrictorTornier · 2006
  • K032685Cemstop Cement RestrictorTeknimed, S.A. · 2003
  • K023680Biobuck Cement RestrictorSmith & Nephew, Inc. · 2002
  • K011943Impro Vise Absorbable Cement Flow RestrictorKensey Nash Corp. · 2001

https://510kreport.com/device/K970779 · printed Nov 5, 2026

Cite this page

510(k) Report. “K970779: Osteonics Tibial Tray Screw Hole Plugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970779

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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