510(k) · Cleared

Cleared

Cement Restrictor, Small and Large

K021765510(k) TraditionalCleared Aug 16, 200279-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

Exactech, Inc. · JDK Prosthesis, Hip, Cement Restrictor

Cleared on Aug 16, 2002 as substantially equivalent to K001932 (Tornier, 2000) and 4 other predicates after a 79-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.

Decided: Aug 16, 2002
Review: 79 days
Class: Class II
Product code: JDK
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K923616 (1992). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK923616 Omniflex-C Uhmwpe Mid-Shaft RestrictorOsteonics Corp. · 1992
This deviceK021765 Cement Restrictor, Small and LargeExactech, Inc. · 2002
Descendant · cites it directly · 0 of its ownK210062 Mectaplug PE IIMedacta International S.A. · 2021

Most influential descendants

Showing 1 of 1 · See all

K210062Mectaplug PE IIMedacta International S.A. · 2021 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923616	Omniflex-C Uhmwpe Mid-Shaft Restrictor	Osteonics Corp.	1992	—
0 (this device)	K021765	Cement Restrictor, Small and Large	Exactech, Inc.	2002	—
+1	K210062	Mectaplug PE II	Medacta International S.A.	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
2000	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2021	1	0

FIG. 1 — Lineage of K021765, 1992–2021Source: 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 JDK? 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 JDK device

#1 K210062 Mectaplug PE IIscore 5.0 · 14 generations · no Class I recall

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What was it cleared against? (5)

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
*	K001932	Tornier Cement Restrictor	Tornier	2000	—
*	K955631	Orthoplug Hard Bone Design Summary page 2 …nier Tornier Cement Restrictor JDI KO01 932 Sunmed, Iiic. Orthoplug Hard Bone Plug LZN K955631 Sunmed, Inc. Orthoplug Soft Bone Plug LZN K95 5 632 Zimmer, Inc. Allen Medulla…	Sunmed, Inc.	1996	—
*	K955632	Orthoplug Soft Bone Design Summary page 2 …nmed, Iiic. Orthoplug Hard Bone Plug LZN K955631 Sunmed, Inc. Orthoplug Soft Bone Plug LZN K95 5 632 Zimmer, Inc. Allen Medullary Cement JDI KO01733 Plugs, Zimmer P…	Sunmed, Inc.	1996	—
*	K001733	Allen Medullary Cement Plugs, Zimmer Poly Plug Intramedullary System, Model 8011 Series…	Zimmer, Inc.	2000	1
*	K923616	Omniflex-C Uhmwpe Mid-Shaft Restrictor Summary page 2 …Plugs, Zimmer Poly Plug Medullary Plugs Osteoiiics Corp. Omniflex-C U H M P E Mid- JDK K9236 16 Shaft Restrictor Device Description The cement restrictor is a single, molded component intended to be…	Osteonics Corp.	1992	—

Also cleared against K001932: 1 other device →

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
K210062	Mectaplug PE II	Medacta International S.A.	2021	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?

1 of the 5 ancestors has a recall of any class.
Of its descendants, K210062 (Medacta International S.A., 2021) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K001932.

How does its category compare?

All JDK devices

JDK Prosthesis, Hip, Cement Restrictor: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDK

1in 2021

2007high 1 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDK

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

Recalls per year · JDK

5in 2011

2007high 6 (2007) · low 0 (2008)2026

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

Adverse event reports per year · JDK

6in 2025

2007high 13 (2019) · low 0 (2017)2025

MAUDE reports naming product code JDK, 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	—	6	3
2008	0	—	0	5
2009	0	—	0	1
2010	0	—	0	2
2011	0	—	5	3
2012	0	—	0	1
2013	0	—	0	3
2014	0	—	0	2
2015	0	—	0	7
2016	0	—	0	2
2017	0	—	0	0
2018	0	—	0	1
2019	0	—	0	13
2020	0	—	0	4
2021	1	—	0	3
2022	0	—	0	4
2023	0	—	0	7
2024	0	—	0	5
2025	0	—	0	6
2026	0	—	0	—

What is it indicated for?

Tecres Cement Restrictors are indicated for the blockage of the femoral medullary canal prior to cement insertion and as an aid to cemented hip arthroplasty procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021765 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021765: Cement Restrictor, Small and Large.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021765

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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