510(k) · Cleared

Cleared

Otomimix

K042516510(k) TraditionalCleared Nov 8, 200453-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

Walter Lorenz Surgical, Inc. · NEA Cement, Ear, Nose And Throat

Cleared on Nov 8, 2004 as substantially equivalent to K990290 (Biomet, Inc., 1999) and 2 other predicates after a 53-day review. Its family tree reaches back 1 generation to 1986. 33 later devices descend from it.

Decided: Nov 8, 2004
Review: 53 days
Class: Class II
Product code: NEA
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K861369 (1986). 3 ancestors in all. 33 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK861369 Incus/Stapes ProsthesisRichards Medical Co., Inc. · 1986
This deviceK042516 OtomimixWalter Lorenz Surgical, Inc. · 2004
Descendant · cites it directly · 30 of its ownK060061 Stryker Injectable CementStryker Corp. · 2006
Descendant · 2 generations on · 10 of its ownK161447 HydroSet XTOrthovita, Inc. · 2016 · Recalled
Descendant · 2 generations on · 8 of its ownK060763 Stryker Injectable CementStryker · 2006 · Recalled
Descendant · 3 generations on · 4 of its ownK173008 SCS 17-01Anika Therapeutics, Inc. · 2017
Descendant · 3 generations on · 3 of its ownK222063 MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc. · 2023

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2006high 7 (2023) · low 0 (2010)2026

Most influential descendants

Showing 5 of 33 · See all

K060061Stryker Injectable CementStryker Corp. · 2006 · cites it directly30descendants
K161447HydroSet XTOrthovita, Inc. · 2016 · 2 generations on10descendants
K060763Stryker Injectable CementStryker · 2006 · 2 generations on8descendants
K173008SCS 17-01Anika Therapeutics, Inc. · 2017 · 3 generations on4descendants
K222063MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc. · 2023 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K861369	Incus/Stapes Prosthesis	Richards Medical Co., Inc.	1986	—
0 (this device)	K042516	Otomimix	Walter Lorenz Surgical, Inc.	2004	—
+1	K060061	Stryker Injectable Cement	Stryker Corp.	2006	—
+2	K161447	HydroSet XT	Orthovita, Inc.	2016	2
+2	K060763	Stryker Injectable Cement	Stryker	2006	1
+3	K173008	SCS 17-01	Anika Therapeutics, Inc.	2017	—
+3	K222063	MONTAGE Settable, Resorbable Bone Putty	Orthocon, Inc.	2023	—

Other ancestors by year cleared

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	3	0
2007	1	0
2008	1	0
2009	1	0
2011	1	0
2014	1	0
2015	1	0
2016	1	0
2017	1	0
2018	2	0
2020	1	0
2021	1	0
2022	3	0
2023	7	0
2024	5	0
2026	3	0

FIG. 1 — Lineage of K042516, 1986–2026Source: 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

Get a 510(k) Report

What was it cleared against? (3)

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
*	K990290	Craniofacial Calcium Phosphate Ceramic Bone Filler Summary page 1 …alence The OtoMimixiM product is believed to be substantially equivalent in application and function to Mimix (Craniofacial Calcium Phosphate Ceramic Bone Void Filler (K990290) Oto-Cem® - OtoTech®, Inc. (KO I 1338) Incus Stapes Prosthesis - Richards Medical, Inc. (K861369) Walter Lorenz Surgical, Inc. i…	Biomet, Inc.	1999	—
*	K011338	Oto-Cem	Ototech, Inc.	2001	—
*	K861369	Incus/Stapes Prosthesis Summary page 1 …tion to Mimix (Craniofacial Calcium Phosphate Ceramic Bone Void Filler (K990290) Oto-Cem® - OtoTech®, Inc. (KO I 1338) Incus Stapes Prosthesis - Richards Medical, Inc. (K861369) Walter Lorenz Surgical, Inc. is a wholly owned subsidiary of Biomet, Inc. The proposed OtoMimixTM product is equivalent in mate…	Richards Medical Co., Inc.	1986	—

Also cleared against K990290: 4 other devices →

What descends from it? (33)

See all 33

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

Number	Device	Applicant	Decided	Descendants
K060061	Stryker Injectable Cement	Stryker Corp.	2006	30
K080032	Envoycem, Model 1640	Envoy Medical Corporation	2008	1
K060750	Stryker Injectable Cement	Stryker Cmf	2006	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?

None of the 3 ancestors has a recall.
Of its descendants, K060061 (Stryker Corp., 2006) has gone furthest, with 30 descendants of its own.
4 other devices also cite its predicate K990290.

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

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?

OtoMimixTM is indicated for the following:

1. Augmentation or coupling of the middle ear ossicles.

2. Attachment of the middle ear ossicles to middle ear implants.

3. Mechanical stabilization of middle ear prostheses

4. Reconstruction of the posterior canal wall

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042516 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042516: Otomimix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042516

Report an extraction error

Are you the manufacturer?

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