510(k) · Decided
Recalled · 2012Kryptonite Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Doctors Research Group, Inc. · GXP Methyl Methacrylate For Cranioplasty
Cleared on Nov 16, 2009 as substantially equivalent to K040152 (Cardinalhealth, 2004) and 1 other predicate after a 189-day review. Its family tree reaches back 2 generations to 1987. It has been recalled once.
- Decided
- Nov 16, 2009
- Review
- 189 days
- Class
- Class II
- Product code
- GXP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K873689 (1987). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K873689 | Cranioplastic, Acrylic Cranioplasty Material | Dentsply Intl. | 1987 | — |
| −1 | K040152 | Bone Cement for Cranioplasty | Cardinalhealth | 2004 | — |
| 0 (this device) | K091382 | Kryptonite Bone Cement | Doctors Research Group, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 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? (2)
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 |
|---|---|---|---|
| * | K040152 | Bone Cement for CranioplastySummary page 1…valent to previously cleared cranioplasty devices and has the same indications for use, design and function - including, but not limited to, Cardinal Health Bone Cement (K040152) and Biomet Craniofacial Acrylic Cement (KO11399). Performance testing demonstrates Kryptonite Bone Cement has equivalent perform… | 2004 |
| * | K011399 | Biomet Craniofacial Acrylic Cement | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 6, 2012 | Not classified | Z-1496-2012 | Component design/selection | Bone cement strength and stiffness fall below specification at body temperature |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 16.6 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All GXP devicesGXP Methyl Methacrylate For Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
Kryptonite Bone Cement TM is a resinous material for repairing cranial defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091382 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091382: Kryptonite Bone Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091382
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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