510(k) · Cleared
ClearedModification to: Injectable Mimix
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 Dec 21, 2001 as substantially equivalent to K990290 (Biomet, Inc., 1999) after a 134-day review. Its family tree reaches back 1 generation to 1999. 45 later devices descend from it.
- Decided
- Dec 21, 2001
- Review
- 134 days
- Class
- Class II
- Product code
- GXP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990290 (1999). 45 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK990290 Craniofacial Calcium Phosphate Ceramic Bone FillerBiomet, Inc. · 1999
- This deviceK012569 Modification to: Injectable MimixBiomet, Inc. · 2001
- 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
- Descendant · 4 generations on · 30 of its ownK060061 Stryker Injectable CementStryker Corp. · 2006
- Descendant · 5 generations on · 10 of its ownK161447 HydroSet XTOrthovita, Inc. · 2016 · Recalled
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- 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
- K060061Stryker Injectable CementStryker Corp. · 2006 · 4 generations on30descendants
- K161447HydroSet XTOrthovita, Inc. · 2016 · 5 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990290 | Craniofacial Calcium Phosphate Ceramic Bone Filler | Biomet, Inc. | 1999 | — |
| 0 (this device) | K012569 | Modification to: Injectable Mimix | Biomet, Inc. | 2001 | — |
| +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 | — |
| +4 | K060061 | Stryker Injectable Cement | Stryker Corp. | 2006 | — |
| +5 | K161447 | HydroSet XT | Orthovita, Inc. | 2016 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K990290 | Craniofacial Calcium Phosphate Ceramic Bone FillerSummary page 1…(882.5330) Device Product Code: 84GXP, 84)]BA Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Craniofacial Calcium Phosphate Ceramic Bone Filler, K990290 Intended Use: The Injectable Mimix™ is a self-setting calcium phosphate cement intended for use in the repair of neurosurgical b… | 1999 |
What descends from it? (45)
See all 452 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?
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 Injectable Mimix™ is a self-setting calcium phosphate cement intended for 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.
The bone filler is not intended for percutaneous injection use.
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/K012569 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012569: Modification to: Injectable Mimix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012569
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026