510(k) · Cleared
ClearedPermatage Flowable, Settable Bone Paste
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthocon, Inc. · GXP Methyl Methacrylate For Cranioplasty
Cleared on Mar 13, 2026 as substantially equivalent to K241027 (Orthocon, Inc., 2024) after a 109-day review. Its family tree reaches back 10 generations to 1987.
- Decided
- Mar 13, 2026
- Review
- 109 days
- Class
- Class II
- Product code
- GXP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K873689 (1987). 20 ancestors in all, the oldest K861369 (1986). No later device cites it as a predicate yet.
- Root · 10 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 6 generations between
- 3 generations backK060061 Stryker Injectable CementStryker Corp. · 2006
- 2 generations backK060763 Stryker Injectable CementStryker · 2006 · Recalled
- 1 generation backK241027 Permatage Settable Bone PuttyOrthocon, Inc. · 2024
- This deviceK253732 Permatage Flowable, Settable Bone PasteOrthocon, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 9 generations backK953339 Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1996
- 8 generations backK973789 Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian…Norian Corp. · 1998
- 7 generations backK991398 Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999
- 6 generations backK021440 Bonesource HacStryker Instruments · 2002
- 5 generations backK032366 Bonesource Hac Fast Setting CementStryker Instruments · 2003
- 4 generations backK043334 Bone Source Hac Rapid Setting CementStryker Instruments · 2005
- 3 generations backK060061 Stryker Injectable CementStryker Corp. · 2006
- 2 generations backK060763 Stryker Injectable CementStryker · 2006 · Recalled
- 1 generation backK241027 Permatage Settable Bone PuttyOrthocon, Inc. · 2024
- This deviceK253732 Permatage Flowable, Settable Bone PasteOrthocon, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K873689 | Cranioplastic, Acrylic Cranioplasty Material | Dentsply Intl. | 1987 | — |
| −9 | K953339 | Bonesource Hydroxyapatite Cement (Hac) | Osteogenics, Inc. | 1996 | — |
| −8 | K973789 | Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair… | Norian Corp. | 1998 | — |
| −7 | K991398 | Bonesource Hydroxyapatite Cement (Hac) Expanded Kit | Stryker Leibinger | 1999 | — |
| −6 | K021440 | Bonesource Hac | Stryker Instruments | 2002 | — |
| −5 | K032366 | Bonesource Hac Fast Setting Cement | Stryker Instruments | 2003 | — |
| −4 | K043334 | Bone Source Hac Rapid Setting Cement | Stryker Instruments | 2005 | — |
| −3 | K060061 | Stryker Injectable Cement | Stryker Corp. | 2006 | — |
| −2 | K060763 | Stryker Injectable Cement | Stryker | 2006 | 1 |
| −1 | K241027 | Permatage Settable Bone Putty | Orthocon, Inc. | 2024 | — |
| 0 (this device) | K253732 | Permatage Flowable, Settable Bone Paste | Orthocon, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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? (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 |
|---|---|---|---|
| * | K241027 | Permatage Settable Bone PuttySummary page 5…s: GXP Regulation: 21 CFR 882.5300 Predicate Devices: Primary Predicate: Orthocon, Inc. Permatage Settable Bone Putty [510(k) Number K241027] Reference Device: Orthocon, Inc. HBP7 Settable Hemostatic Bone Putty [510(k) Number K202363] Device… | 2024 |
| † | K202363 | HBP7 Settable Hemostatic Bone Putty | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 39 years and passes through 8 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 20 ancestors have a recall of any class.
- 1 other device also cites its predicate K241027.
How does its category compare?
All GXP devicesGXP Methyl Methacrylate For Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Orthocon Permatage Flowable, Settable Bone Paste is a self-setting cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects. Permatage Flowable, Settable Bone Paste should be used only in skeletally mature individuals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253732 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253732: Permatage Flowable, Settable Bone Paste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253732
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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