510(k) Report

510(k) · Cleared

Cleared

Oto-Cem

K011338510(k) TraditionalCleared Sep 13, 2001134-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

Ototech, Inc. · NEA Cement, Ear, Nose And Throat

Cleared on Sep 13, 2001 after a 134-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 34 later devices descend from it.

Decided
Sep 13, 2001
Review
134 days
Class
Class II
Product code
NEA
Recalls
None
Predicates
0

34 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2008: 1 descendant cleared2006: 3 descendants cleared2014: 1 descendant cleared2009: 1 descendant cleared2016: 1 descendant cleared2018: 2 descendants cleared2007: 1 descendant cleared2024: 5 descendants cleared2023: 7 descendants cleared2015: 1 descendant cleared2011: 1 descendant cleared2017: 1 descendant cleared2022: 3 descendants cleared2020: 1 descendant cleared2021: 1 descendant cleared2026: 3 descendants cleared200020052010201520202025
  1. This deviceK011338 Oto-CemOtotech, Inc. · 2001
  2. Descendant · cites it directly · 33 of its ownK042516 OtomimixWalter Lorenz Surgical, Inc. · 2004
  3. Descendant · 2 generations on · 30 of its ownK060061 Stryker Injectable CementStryker Corp. · 2006
  4. Descendant · 3 generations on · 10 of its ownK161447 HydroSet XTOrthovita, Inc. · 2016 · Recalled
  5. Descendant · 3 generations on · 8 of its ownK060763 Stryker Injectable CementStryker · 2006 · Recalled
  6. Descendant · 4 generations on · 4 of its ownK173008 SCS 17-01Anika Therapeutics, Inc. · 2017

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2004: 12006: 32007: 12008: 12009: 12011: 12014: 12015: 12016: 12017: 12018: 22020: 12021: 12022: 32023: 72024: 52026: 3
2004high 7 (2023) · low 0 (2005)2026

Most influential descendants

Showing 5 of 34 · See all
  • K042516OtomimixWalter Lorenz Surgical, Inc. · 2004 · cites it directly33descendants
  • K060061Stryker Injectable CementStryker Corp. · 2006 · 2 generations on30descendants
  • K161447HydroSet XTOrthovita, Inc. · 2016 · 3 generations on10descendants
  • K060763Stryker Injectable CementStryker · 2006 · 3 generations on8descendants
  • K173008SCS 17-01Anika Therapeutics, Inc. · 2017 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011338Oto-CemOtotech, Inc.2001—
+1K042516OtomimixWalter Lorenz Surgical, Inc.2004—
+2K060061Stryker Injectable CementStryker Corp.2006—
+3K161447HydroSet XTOrthovita, Inc.20162
+3K060763Stryker Injectable CementStryker20061
+4K173008SCS 17-01Anika Therapeutics, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200630
200710
200810
200910
201110
201410
201510
201610
201710
201820
202010
202110
202230
202370
202450
202630
FIG. 1 — Lineage of K011338, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (34)

See all 34

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

NumberDeviceApplicantDecidedDescendants
K042516OtomimixWalter Lorenz Surgical, Inc.200433
K080032Envoycem, Model 1640Envoy Medical Corporation20081

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, K042516 (Walter Lorenz Surgical, Inc., 2004) has gone furthest, with 33 descendants of its own.

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.

FDA decisions per year · NEA

1in 2014

2008: 12014: 1
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

2013: 12014: 22017: 82018: 22019: 92020: 32023: 92024: 52025: 2
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—00
20090—00
20100—00
20110—00
20120—00
20130—01
20141—02
20150—00
20160—00
20170—08
20180—02
20190—09
20200—03
20210—00
20220—00
20230—09
20240—05
20250—02
20260—0—

Recent decisions in NEA

The NEA category page

  • K140644ProcemOtotronix, LLC · 2014
  • K080032Envoycem, Model 1640Envoy Medical Corporation · 2008
  • K060750Stryker Injectable CementStryker Cmf · 2006
  • K042516OtomimixWalter Lorenz Surgical, Inc. · 2004
  • K003567Serenocem, Model BC 010Corinthian Medical, Ltd. · 2001

https://510kreport.com/device/K011338 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011338: Oto-Cem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011338

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026