510(k) · Cleared
ClearedCraniofacial Calcium Phosphate Ceramic Bone Filler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · GXP Methyl Methacrylate For Cranioplasty
Cleared on Nov 18, 1999 after a 293-day review. The FDA summary names no predicate by number. 50 later devices descend from it.
- Decided
- Nov 18, 1999
- Review
- 293 days
- Class
- Class II
- Product code
- GXP
- Recalls
- None
- Predicates
- 0
50 later devices descend from it, 5 citing it directly.
- This deviceK990290 Craniofacial Calcium Phosphate Ceramic Bone FillerBiomet, Inc. · 1999
- Descendant · cites it directly · 45 of its ownK012569 Modification to: Injectable MimixBiomet, Inc. · 2001
- Descendant · cites it directly · 43 of its ownK023718 Quickset Mimix Bone Void FillerWalter Lorenz Surgical, Inc. · 2002
- Descendant · cites it directly · 43 of its ownK021440 Bonesource HacStryker Instruments · 2002
- Descendant · 2 generations on · 41 of its ownK032366 Bonesource Hac Fast Setting CementStryker Instruments · 2003
- Descendant · 3 generations on · 36 of its ownK043334 Bone Source Hac Rapid Setting CementStryker Instruments · 2005
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K012569Modification to: Injectable MimixBiomet, Inc. · 2001 · cites it directly45descendants
- K023718Quickset Mimix Bone Void FillerWalter Lorenz Surgical, Inc. · 2002 · cites it directly43descendants
- K021440Bonesource HacStryker Instruments · 2002 · cites it directly43descendants
- K032366Bonesource Hac Fast Setting CementStryker Instruments · 2003 · 2 generations on41descendants
- K043334Bone Source Hac Rapid Setting CementStryker Instruments · 2005 · 3 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990290 | Craniofacial Calcium Phosphate Ceramic Bone Filler | Biomet, Inc. | 1999 | — |
| +1 | K012569 | Modification to: Injectable Mimix | Biomet, Inc. | 2001 | — |
| +1 | K023718 | Quickset Mimix Bone Void Filler | Walter Lorenz Surgical, Inc. | 2002 | — |
| +1 | K021440 | Bonesource Hac | Stryker Instruments | 2002 | — |
| +2 | K032366 | Bonesource Hac Fast Setting Cement | Stryker Instruments | 2003 | — |
| +3 | K043334 | Bone Source Hac Rapid Setting Cement | Stryker Instruments | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 7 | 0 |
| 2024 | 5 | 0 |
| 2026 | 4 | 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 GXP? 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 GXP device
- #1 K241027 Permatage Settable Bone Puttyscore 16.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (50)
See all 505 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K012569 (Biomet, Inc., 2001) has gone furthest, with 45 descendants of its own.
How does its category compare?
All GXP devicesGXP Methyl Methacrylate For Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GXP
4so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · GXP
87in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXP
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXP
1in 2025
MAUDE reports naming product code GXP, 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 | 3 | 87 | 0 | 8 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 1 | — | 1 | 22 |
| 2010 | 1 | — | 0 | 59 |
| 2011 | 0 | — | 1 | 31 |
| 2012 | 0 | — | 1 | 28 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 0 | — | 0 | 19 |
| 2015 | 1 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 17 |
| 2017 | 1 | — | 0 | 16 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 1 | — | 2 | 9 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 4 | 85 | 0 | — |
What is it indicated for?
The Craniofacial Calcium Phosphate Ceramic Bone Filler is a self-setting calcium phosphate cement intended for the use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990290 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990290: Craniofacial Calcium Phosphate Ceramic Bone Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990290
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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