510(k) · Cleared
ClearedQuickset Mimix Bone Void Filler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Walter Lorenz Surgical, Inc. · GXP Methyl Methacrylate For Cranioplasty
Cleared on Dec 4, 2002 as substantially equivalent to K990290 (Biomet, Inc., 1999) after a 29-day review. Its family tree reaches back 1 generation to 1999. 43 later devices descend from it.
- Decided
- Dec 4, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- GXP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990290 (1999). 43 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK990290 Craniofacial Calcium Phosphate Ceramic Bone FillerBiomet, Inc. · 1999
- This deviceK023718 Quickset Mimix Bone Void FillerWalter Lorenz Surgical, Inc. · 2002
- Descendant · cites it directly · 41 of its ownK032366 Bonesource Hac Fast Setting CementStryker Instruments · 2003
- Descendant · 2 generations on · 36 of its ownK043334 Bone Source Hac Rapid Setting CementStryker Instruments · 2005
- Descendant · 3 generations on · 30 of its ownK060061 Stryker Injectable CementStryker Corp. · 2006
- Descendant · 4 generations on · 10 of its ownK161447 HydroSet XTOrthovita, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 8 of its ownK060763 Stryker Injectable CementStryker · 2006 · Recalled
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K032366Bonesource Hac Fast Setting CementStryker Instruments · 2003 · cites it directly41descendants
- K043334Bone Source Hac Rapid Setting CementStryker Instruments · 2005 · 2 generations on36descendants
- K060061Stryker Injectable CementStryker Corp. · 2006 · 3 generations on30descendants
- K161447HydroSet XTOrthovita, Inc. · 2016 · 4 generations on10descendants
- K060763Stryker Injectable CementStryker · 2006 · 3 generations on8descendants
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) | K023718 | Quickset Mimix Bone Void Filler | Walter Lorenz Surgical, Inc. | 2002 | — |
| +1 | K032366 | Bonesource Hac Fast Setting Cement | Stryker Instruments | 2003 | — |
| +2 | K043334 | Bone Source Hac Rapid Setting Cement | Stryker Instruments | 2005 | — |
| +3 | K060061 | Stryker Injectable Cement | Stryker Corp. | 2006 | — |
| +4 | K161447 | HydroSet XT | Orthovita, Inc. | 2016 | 2 |
| +3 | K060763 | Stryker Injectable Cement | Stryker | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 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…uct Code: 84GXP Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Mimix'" Bone Void Filler (K990290) Indicated Use: The QuickSet MimixTMBone Void Filler is a self-setting calcium phosphate cement indicated for the following cran… | 1999 |
What descends from it? (43)
See all 432 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 QuickSet Mimix™ Bone Void Filler is a self-setting calcium phosphate cement indicated for
the following craniofacial procedures:
1. Repair of neurosurgical burr holes
2. Craniotomy cuts and other cranial defects
3. Augmentation or restoration of bony contour in the craniofacial skeleton area no larger
that 25 cm2
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023718: Quickset Mimix Bone Void Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023718
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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