510(k) · Cleared

Cleared

Howmedica Osteonics Tibial Tray Screw Hole Plugs

K032479510(k) SpecialCleared Sep 4, 200323-day reviewClass II21 CFR 888.3560

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

Howmedica Osteonics Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Sep 4, 2003 as substantially equivalent to K970779 (Osteonics Corp., 1997) after a 23-day review. Its family tree reaches back 1 generation to 1997. 7 later devices descend from it.

Decided: Sep 4, 2003
Review: 23 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K970779 (1997). 7 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK970779 Osteonics Tibial Tray Screw Hole PlugsOsteonics Corp. · 1997
This deviceK032479 Howmedica Osteonics Tibial Tray Screw Hole PlugsHowmedica Osteonics Corp. · 2003
Descendant · cites it directly · 5 of its ownK053390 Columbus (CR) Total Knee SystemAesculap, Inc. · 2006 · Recalled
Descendant · 2 generations on · 4 of its ownK120955 Columbus Total Knee System as Columbus Revision Knee System Enduro…Aesculap Implant Systems, LLC · 2012
Descendant · 2 generations on · 3 of its ownK143443 VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC · 2015
Descendant · 3 generations on · 2 of its ownK191765 OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019
Descendant · 4 generations on · 0 of its ownK252044 Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2006high 1 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 7 · See all

K053390Columbus (CR) Total Knee SystemAesculap, Inc. · 2006 · cites it directly5descendants
K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC · 2012 · 2 generations on4descendants
K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC · 2015 · 2 generations on3descendants
K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019 · 3 generations on2descendants
K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K970779	Osteonics Tibial Tray Screw Hole Plugs	Osteonics Corp.	1997	—
0 (this device)	K032479	Howmedica Osteonics Tibial Tray Screw Hole Plugs	Howmedica Osteonics Corp.	2003	—
+1	K053390	Columbus (CR) Total Knee System	Aesculap, Inc.	2006	1
+2	K120955	Columbus Total Knee System as Columbus Revision Knee System Enduro Knee System	Aesculap Implant Systems, LLC	2012	—
+2	K143443	VEGA Knee System, Columbus Total Knee System	Aesculap Implants Systems, LLC	2015	—
+3	K191765	OMNI TiN Coated Apex Knee™ System	Omni Life Science, Inc.	2019	—
+4	K252044	Triathlon® Total Knee System - Triathlon® Gold Femoral Components	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2010	1	0
2012	1	0
2015	1	0
2019	1	0
2021	1	0
2025	1	0

FIG. 1 — Lineage of K032479, 1997–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JWH? 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 JWH device

#1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K970779	Osteonics Tibial Tray Screw Hole Plugs Summary page 1 …al Tray Screw Hole Plugs are a line extension to the existing Howmedica Osteonics Tibial Tray Screw Hole plugs found substantially equivalent in premarket notification K970779. The predicate Tibial Tray Screw Hole Plugs are fabricated from low-density polyethylene, and are circular in design. The subjec…	Osteonics Corp.	1997	—

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K053390	Columbus (CR) Total Knee System	Aesculap, Inc.	2006	5
K101032	Cardo Medical Femoral Cement Restrictor, Model 503-MCRX	Cardo Medical, Inc.	2010	0

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?

Its one ancestor has no recall.
Of its descendants, K053390 (Aesculap, Inc., 2006) has gone furthest, with 5 descendants of its own.

How does its category compare?

All JWH devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JWH

20in 2025

2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

2007high 109 (2009) · low 2 (2020)2026

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

Adverse event reports per year · JWH

9,306in 2025

2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, 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	18	74	14	1,305
2008	17	81	10	1,483
2009	11	168	109	1,870
2010	19	85	32	3,286
2011	25	87	27	5,133
2012	33	85	85	5,203
2013	31	128	31	6,135
2014	33	98	13	6,722
2015	27	87	11	6,881
2016	18	88	17	7,586
2017	25	118	61	12,263
2018	25	90	14	14,071
2019	28	133	5	14,987
2020	22	59	2	12,592
2021	24	61	8	9,408
2022	17	56	12	8,364
2023	20	57	67	8,947
2024	19	89	7	10,828
2025	20	55	2	9,306
2026	12	63	4	—

What is it indicated for?

The subject Tibial Tray Screw Hole Plugs are intended to occlude all tibial tray screw holes not occupied by bone screws. The Tibial Tray Screw Hole Plugs are factory assembled to the tibial tray screw holes. Intraoperatively, the surgeon will remove the plugs from whichever screw holes will be filled with a bone screw. By occluding the tibial tray screw holes, the Tibial Tray Screw Hole Plugs help prevent intrusion of bone cement onto the tibial tray.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032479 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032479: Howmedica 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/K032479

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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