510(k) · Cleared
ClearedMontage Flowable Settable, Resorbable 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 Feb 16, 2024 as substantially equivalent to K060763 (Stryker, 2006) after a 158-day review. Its family tree reaches back 9 generations to 1987.
- Decided
- Feb 16, 2024
- Review
- 158 days
- Class
- Class II
- Product code
- GXP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K873689 (1987). 19 ancestors in all, the oldest K861369 (1986). No later device cites it as a predicate yet.
- Root · 9 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 5 generations between
- 3 generations backK043334 Bone Source Hac Rapid Setting CementStryker Instruments · 2005
- 2 generations backK060061 Stryker Injectable CementStryker Corp. · 2006
- 1 generation backK060763 Stryker Injectable CementStryker · 2006 · Recalled
- This deviceK232771 Montage Flowable Settable, Resorbable Bone PasteOrthocon, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 8 generations backK953339 Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1996
- 7 generations backK973789 Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian…Norian Corp. · 1998
- 6 generations backK991398 Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999
- 5 generations backK021440 Bonesource HacStryker Instruments · 2002
- 4 generations backK032366 Bonesource Hac Fast Setting CementStryker Instruments · 2003
- 3 generations backK043334 Bone Source Hac Rapid Setting CementStryker Instruments · 2005
- 2 generations backK060061 Stryker Injectable CementStryker Corp. · 2006
- 1 generation backK060763 Stryker Injectable CementStryker · 2006 · Recalled
- This deviceK232771 Montage Flowable Settable, Resorbable Bone PasteOrthocon, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K873689 | Cranioplastic, Acrylic Cranioplasty Material | Dentsply Intl. | 1987 | — |
| −8 | K953339 | Bonesource Hydroxyapatite Cement (Hac) | Osteogenics, Inc. | 1996 | — |
| −7 | K973789 | Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair… | Norian Corp. | 1998 | — |
| −6 | K991398 | Bonesource Hydroxyapatite Cement (Hac) Expanded Kit | Stryker Leibinger | 1999 | — |
| −5 | K021440 | Bonesource Hac | Stryker Instruments | 2002 | — |
| −4 | K032366 | Bonesource Hac Fast Setting Cement | Stryker Instruments | 2003 | — |
| −3 | K043334 | Bone Source Hac Rapid Setting Cement | Stryker Instruments | 2005 | — |
| −2 | K060061 | Stryker Injectable Cement | Stryker Corp. | 2006 | — |
| −1 | K060763 | Stryker Injectable Cement | Stryker | 2006 | 1 |
| 0 (this device) | K232771 | Montage Flowable Settable, Resorbable Bone Paste | Orthocon, Inc. | 2024 | — |
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 |
|---|---|---|---|
| * | K060763 | Stryker Injectable CementSummary page 5…lation: 21 CFR 882.5300 Predicate Devices: Primary Predicate: Stryker HydroSet Injectable Cement [510(k) Number K060763] Reference Devices: Orthocon, Inc. HBP6 Flowable Settable, Resorbable Hemostatic Bone Paste… | 2006 |
| † | K193052 | HBP6 Settable, Resorbable Hemostatic Bone Paste | 2020 |
| † | K231270 | Montage Flowable Settable, Resorbable Bone Paste | 2023 |
| † | K221933 | MONTAGE Settable, Resorbable Bone Putty | 2023 |
| † | K191140 | MONTAGE-QS Settable, Resorbable Hemostatic Bone | 2019 |
| † | K231903 | Montage-QS Settable, Resorbable Bone Putty | 2023 |
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 37 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 19 ancestors have a recall of any class.
- 4 other devices also cite its predicate K060763.
How does its category compare?
All GXP devicesGXP Methyl Methacrylate For Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Montage Flowable Settable, Resorbable Bone Paste 1s a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface area no larger than 25cm2. Montage Flowable Settable, Resorbable Bone Paste should be used only in skeletally mature mdividuals.
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/K232771 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232771: Montage Flowable Settable, Resorbable Bone Paste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232771
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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