510(k) · Cleared

Recalled · 2009

Coonrad/Morrey Elbow Cement Restrictor

K040389510(k) TraditionalCleared May 17, 200490-day reviewClass II21 CFR 888.3150Recalls 1

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

Zimmer, Inc. · JDC Prosthesis, Elbow, Constrained, Cemented

Cleared on May 17, 2004 as substantially equivalent to K001733 (Zimmer, Inc., 2000) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it. It has been recalled once.

Decided: May 17, 2004
Review: 90 days
Class: Class II
Product code: JDC
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K950312 (1995). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK950312 Alpha SystemZimmer, Inc. · 1995 · Recalled
This deviceK040389 Coonrad/Morrey Elbow Cement RestrictorZimmer, Inc. · 2004
Descendant · cites it directly · 0 of its ownK181307 Zimmer Nexel Total Elbow, Connrad/Morrey Total ElbowZimmer, Inc. · 2019

Most influential descendants

Showing 1 of 1 · See all

K181307Zimmer Nexel Total Elbow, Connrad/Morrey Total ElbowZimmer, Inc. · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K950312	Alpha System	Zimmer, Inc.	1995	3
0 (this device)	K040389	Coonrad/Morrey Elbow Cement Restrictor	Zimmer, Inc.	2004	—
+1	K181307	Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow	Zimmer, Inc.	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0

FIG. 1 — Lineage of K040389, 1995–2019Source: 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 JDC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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	Applicant	Decided	Recalls
*	K001733	Allen Medullary Cement Plugs, Zimmer Poly Plug Intramedullary System, Model 8011 Series…	Zimmer, Inc.	2000	1
*	K950312	Alpha System Summary page 1 …Zimmer Poly-PlugT Intramedullary System, M K950312, cleared May 17, 1995 Device Description: The Coonrad/Morrey Elbow Cement Restrictor is…	Zimmer, Inc.	1995	3

Also cleared against K001733: 4 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K181307	Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow	Zimmer, Inc.	2019	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 8, 2009	Not classified	Z-1700-2009	Packaging process control	The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.

No ancestor or descendant has a Class I recall.

What does this lineage say?

2 of the 2 ancestors have a recall of any class.
Of its descendants, K181307 (Zimmer, Inc., 2019) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K001733.

How does its category compare?

All JDC devices

JDC Prosthesis, Elbow, Constrained, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDC

2in 2019

2007high 2 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDC

Too few JDC 510(k)s in any year since 2007 to give a median.

Recalls per year · JDC

2in 2019

2007high 6 (2009) · low 0 (2007)2026

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

Adverse event reports per year · JDC

212in 2025

2007high 401 (2017) · low 33 (2007)2025

MAUDE reports naming product code JDC, 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	33
2008	0	—	2	47
2009	1	—	6	45
2010	0	—	0	86
2011	0	—	2	62
2012	0	—	2	79
2013	1	—	0	74
2014	0	—	0	79
2015	1	—	0	239
2016	1	—	0	176
2017	0	—	0	401
2018	0	—	0	248
2019	2	—	2	190
2020	0	—	0	179
2021	0	—	0	157
2022	0	—	0	129
2023	0	—	0	189
2024	0	—	0	175
2025	0	—	0	212
2026	0	—	1	—

What is it indicated for?

Intramedullary cement plugs are indicated for use in total joint arthroplasty to control, restrict or impede the flow of cement.

The larger intramedullary cement plugs are useful in revision surgery where a wide, smooth intramedullary canal must be plugged.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040389 · printed Nov 3, 2026

Cite this page

510(k) Report. “K040389: Coonrad/Morrey Elbow Cement Restrictor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040389

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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