510(k) · Cleared
ClearedMontage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthocon, Inc. · GXR Cover, Burr Hole
Cleared on Mar 16, 2026 as substantially equivalent to K181539 (Ossdsign AB, 2018) after a 165-day review. Its family tree reaches back 10 generations to 1987.
- Decided
- Mar 16, 2026
- Review
- 165 days
- Class
- Class II
- Product code
- GXR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K873689 (1987). 51 ancestors in all, the oldest K761228 (1976). No later device cites it as a predicate yet.
- Root · 10 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 6 generations between
- 3 generations backK051603 Stryker Injectable CementStryker Leibinger Micro Implants · 2005
- 2 generations backK140309 CranioplugOssdsign AB · 2014
- 1 generation backK181539 OSSDSIGN CranioplugOssdsign AB · 2018
- This deviceK253447 Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, 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 backK051603 Stryker Injectable CementStryker Leibinger Micro Implants · 2005
- 2 generations backK140309 CranioplugOssdsign AB · 2014
- 1 generation backK181539 OSSDSIGN CranioplugOssdsign AB · 2018
- This deviceK253447 Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, 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 | K051603 | Stryker Injectable Cement | Stryker Leibinger Micro Implants | 2005 | — |
| −2 | K140309 | Cranioplug | Ossdsign AB | 2014 | — |
| −1 | K181539 | OSSDSIGN Cranioplug | Ossdsign AB | 2018 | — |
| 0 (this device) | K253447 | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) | Orthocon, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1986 | 3 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 6 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2012 | 2 | 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 GXR? 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 GXR device
- #1 K240137 Cranial LOOP, Cranial LOOP L and Cranial LOOP…score 7.8 · 4 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 |
|---|---|---|---|
| * | K181539 | OSSDSIGN CranioplugSummary page 5…Name: Burr Hole Cover Classification: Class Il Product codes: GXR Regulation: 21 CFR 882.5250 Predicate Devices: Primary Predicate: OSSDSIGN Cranioplug [510(k) Number K181539] Reference Devices: Orthocon, Inc. Montage Flowable Settable, Resorbable Bone Paste 510(k) Number K232771 Orthocon, Inc. HBP6 F… | 2018 |
| † | K232771 | Montage Flowable Settable, Resorbable Bone Paste | 2024 |
| † | K193052 | HBP6 Settable, Resorbable Hemostatic Bone Paste | 2020 |
| † | K231270 | Montage Flowable Settable, Resorbable Bone Paste | 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 39 years and passes through 8 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 51 ancestors have a recall of any class.
How does its category compare?
All GXR devicesGXR Cover, Burr Hole: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · GXR
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GXR
116in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXR
No recall names GXR since 2007.
Adverse event reports per year · GXR
10in 2025
MAUDE reports naming product code GXR, 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 | 1 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 4 | 116 | 0 | 4 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 2 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 2 | — | 0 | 45 |
| 2019 | 0 | — | 0 | 28 |
| 2020 | 2 | — | 0 | 16 |
| 2021 | 0 | — | 0 | 28 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 1 | — | 0 | 11 |
| 2024 | 1 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Orthocon Montage Flowable Settable, Resorbable Bone Paste is a self-setting cement indicated for fixation of bone flaps following craniotomy. Montage Flowable Settable, Resorbable Bone Paste should be used only in skeletally mature individuals.
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/K253447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253447: Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253447
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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