510(k) · Cleared
ClearedFast Set Putty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · GXP Methyl Methacrylate For Cranioplasty
Cleared on Feb 7, 2002 after a 181-day review. The FDA summary names no predicate by number. 17 later devices descend from it.
- Decided
- Feb 7, 2002
- Review
- 181 days
- Class
- Class II
- Product code
- GXP
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 4 citing it directly.
- This deviceK012589 Fast Set PuttySynthes (Usa) · 2002
- Descendant · cites it directly · 10 of its ownK041842 Norian SRS Fast Set PuttySynthes (Usa) · 2004
- Descendant · 2 generations on · 3 of its ownK051603 Stryker Injectable CementStryker Leibinger Micro Implants · 2005
- Descendant · cites it directly · 3 of its ownK042072 Callos CMF Bone Void FillerSkeletal Kinetics, LLC · 2004 · Recalled
- Descendant · 3 generations on · 2 of its ownK140309 CranioplugOssdsign AB · 2014
- Descendant · 2 generations on · 2 of its ownK071004 Osteocrete Bone Void FillerBone Solutions, Inc. · 2009
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K041842Norian SRS Fast Set PuttySynthes (Usa) · 2004 · cites it directly10descendants
- K051603Stryker Injectable CementStryker Leibinger Micro Implants · 2005 · 2 generations on3descendants
- K042072Callos CMF Bone Void FillerSkeletal Kinetics, LLC · 2004 · cites it directly3descendants
- K140309CranioplugOssdsign AB · 2014 · 3 generations on2descendants
- K071004Osteocrete Bone Void FillerBone Solutions, Inc. · 2009 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012589 | Fast Set Putty | Synthes (Usa) | 2002 | — |
| +1 | K041842 | Norian SRS Fast Set Putty | Synthes (Usa) | 2004 | — |
| +2 | K051603 | Stryker Injectable Cement | Stryker Leibinger Micro Implants | 2005 | — |
| +1 | K042072 | Callos CMF Bone Void Filler | Skeletal Kinetics, LLC | 2004 | 10 |
| +3 | K140309 | Cranioplug | Ossdsign AB | 2014 | — |
| +2 | K071004 | Osteocrete Bone Void Filler | Bone Solutions, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2026 | 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?
The FDA summary names no predicate by number.
What descends from it? (17)
See all 174 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, K041842 (Synthes (Usa), 2004) has gone furthest, with 10 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?
Fast Set Putty is indicated for repairing or filling craniofacial defects and craniotomy cuts with a surface area no larger than 25cm’. Fast Set Putty is also indicated for the restoration or augmentation of bony contours of the craniofacial skeleton, including the fronto-orbital, malar and mental areas.
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/K012589 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012589: Fast Set Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012589
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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