510(k) · Cleared
ClearedStryker Injectable Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Cmf · NEA Cement, Ear, Nose And Throat
Cleared on Apr 19, 2006 as substantially equivalent to K060061 (Stryker Corp., 2006) and 2 other predicates after a 29-day review. Its family tree reaches back 8 generations to 1987.
- Decided
- Apr 19, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- NEA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K873689 (1987). 18 ancestors in all, the oldest K861369 (1986). No later device cites it as a predicate yet.
- Root · 8 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 7 generations backK953339 Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1996
- 6 generations backK973789 Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian…Norian Corp. · 1998
- 5 generations backK991398 Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999
- 4 generations backK021440 Bonesource HacStryker Instruments · 2002
- 3 generations backK032366 Bonesource Hac Fast Setting CementStryker Instruments · 2003
- 2 generations backK043334 Bone Source Hac Rapid Setting CementStryker Instruments · 2005
- 1 generation backK060061 Stryker Injectable CementStryker Corp. · 2006
- This deviceK060750 Stryker Injectable CementStryker Cmf · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K873689 | Cranioplastic, Acrylic Cranioplasty Material | Dentsply Intl. | 1987 | — |
| −7 | K953339 | Bonesource Hydroxyapatite Cement (Hac) | Osteogenics, Inc. | 1996 | — |
| −6 | K973789 | Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair… | Norian Corp. | 1998 | — |
| −5 | K991398 | Bonesource Hydroxyapatite Cement (Hac) Expanded Kit | Stryker Leibinger | 1999 | — |
| −4 | K021440 | Bonesource Hac | Stryker Instruments | 2002 | — |
| −3 | K032366 | Bonesource Hac Fast Setting Cement | Stryker Instruments | 2003 | — |
| −2 | K043334 | Bone Source Hac Rapid Setting Cement | Stryker Instruments | 2005 | — |
| −1 | K060061 | Stryker Injectable Cement | Stryker Corp. | 2006 | — |
| 0 (this device) | K060750 | Stryker Injectable Cement | Stryker Cmf | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K060061 | Stryker Injectable CementSummary page 2…ectable Cement, K043334 Stryker® HAC Rapid Set Cement, and K042516 Walter Lorenz Otomimix. Stryker' K060061 K043334 K Injectable Stryker Stryker® 042561… | 2006 |
| * | K043334 | Bone Source Hac Rapid Setting CementSummary page 1…sterior canal wall. Substantial Equivalency Information Stryker® Injectable Cement is substantially equivalent to legally marketed K06006[ Stryker® Injectable Cement, K043334 Stryker® HAC Rapid Set Cement, and K042516 Walter Lorenz Otomimix.… | 2005 |
| * | K042516 | OtomimixSummary page 1…cy Information Stryker® Injectable Cement is substantially equivalent to legally marketed K06006[ Stryker® Injectable Cement, K043334 Stryker® HAC Rapid Set Cement, and K042516 Walter Lorenz Otomimix. Stryker' K060061 K043334 K… | 2004 |
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 19 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 18 ancestors has a recall of any class.
- 6 other devices also cite its predicate K060061.
How does its category compare?
All NEA devicesNEA Cement, Ear, Nose And Throat: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NEA
1in 2014
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Stryker® Injectable Cement is indicated for use in the following: augmentation or coupling of the middle ear ossicles, attachment of the middle ear ossicles to middle ear implants, mechanical stabilization of middle ear prostheses, and the reconstruction of the posterior canal wall.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060750 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060750: Stryker Injectable Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060750
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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