510(k) · Cleared

Cleared

Procem

K140644510(k) TraditionalCleared Jun 19, 201498-day reviewClass II21 CFR 872.3275

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

Ototronix, LLC · NEA Cement, Ear, Nose And Throat

Cleared on Jun 19, 2014 as substantially equivalent to K003567 (Corinthian Medical, Ltd., 2001) and 1 other predicate after a 98-day review. Its family tree reaches back 3 generations to 1986.

Decided: Jun 19, 2014
Review: 98 days
Class: Class II
Product code: NEA
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K861369 (1986). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK861369 Incus/Stapes ProsthesisRichards Medical Co., Inc. · 1986
2 generations backK042516 OtomimixWalter Lorenz Surgical, Inc. · 2004
1 generation backK080032 Envoycem, Model 1640Envoy Medical Corporation · 2008
This deviceK140644 ProcemOtotronix, LLC · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K861369	Incus/Stapes Prosthesis	Richards Medical Co., Inc.	1986	—
−2	K042516	Otomimix	Walter Lorenz Surgical, Inc.	2004	—
−1	K080032	Envoycem, Model 1640	Envoy Medical Corporation	2008	—
0 (this device)	K140644	Procem	Ototronix, LLC	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	2	0

FIG. 1 — Lineage of K140644, 1986–2014Source: 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 NEA? 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
*	K003567	Serenocem, Model BC 010	Corinthian Medical, Ltd.	2001	—
*	K080032	Envoycem, Model 1640 Summary page 2 …4 Substantial Equivalence: Ototronix believes that ProCenmm is substantially equivalent to the following devices: * SerenoCem, KOO03567 * EnvoyCem, K080032 ProCerm is a glass lonomer cement as is EnvoyCem and SerenoCem and has essentially the same intended use as the predicate devices…	Envoy Medical Corporation	2008	—

Also cleared against K003567: 1 other device →

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?

The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
None of the 6 ancestors has a recall.
1 other device also cites its predicate K003567.

How does its category compare?

All NEA devices

NEA Cement, Ear, Nose And Throat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · NEA

1in 2014

2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NEA

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

Recalls per year · NEA

No recall names NEA since 2007.

Adverse event reports per year · NEA

2in 2025

2007high 9 (2019) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	1	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	1
2014	1	—	2
2015	0	—	0
2016	0	—	0
2017	0	—	8
2018	0	—	2
2019	0	—	9
2020	0	—	3
2021	0	—	0
2022	0	—	0
2023	0	—	9
2024	0	—	5
2025	0	—	2
2026	0	—	—

What is it indicated for?

ProCemTM is intended for non-weight bearing applications in Otologic surgery, such as:

1. Reconstruction of ossicular bones or mechanical coupling of the ossicular chain.

2. Mechanical stabilization of middle ear and cochlear implants.

3. Attachment of middle ear implants to the ossicular bones.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K140644 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140644: Procem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140644

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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