510(k) · Cleared
ClearedPermatage Flowable, Settable Hemostatic Bone Paste
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthocon, Inc. · MTJ Wax, Bone
Cleared on Jun 3, 2026 as substantially equivalent to K202363 (Orthocon, Inc., 2021) after a 34-day review. Its family tree reaches back 13 generations to 1979.
- Decided
- Jun 3, 2026
- Review
- 34 days
- Class
- Class U
- Product code
- MTJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K791495 (1979). 21 ancestors in all. No later device cites it as a predicate yet.
- Root · 13 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
- 9 generations between
- 3 generations backK141502 HBP4 Hardening, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2014
- 2 generations backK152005 MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2015
- 1 generation backK202363 HBP7 Settable Hemostatic Bone PuttyOrthocon, Inc. · 2021
- This deviceK261439 Permatage Flowable, Settable Hemostatic Bone PasteOrthocon, Inc. · 2026
Show all 13 generations
- Root · 13 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
- 12 generations backK971680 Auto Suture Bone WaxUnited States Surgical, A Division of Tyco Healthc · 1997
- 11 generations backK041363 Aoc Bone WaxCeremed, Inc. · 2004 · Recalled
- 10 generations backK050440 Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene…Ceremed, Inc. · 2005
- 9 generations backK052528 Aoc Bone Wax Ostene, Osteotene and CereteneCeremed, Inc. · 2005
- 8 generations backK062280 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and…Ceremed, Inc. · 2006
- 7 generations backK070093 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, ActipasteCeremed, Inc. · 2007
- 6 generations backK082491 Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc…Ceremed, Inc. · 2008
- 5 generations backK091636 Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc. · 2009
- 4 generations backK102071 Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc. · 2010
- 3 generations backK141502 HBP4 Hardening, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2014
- 2 generations backK152005 MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2015
- 1 generation backK202363 HBP7 Settable Hemostatic Bone PuttyOrthocon, Inc. · 2021
- This deviceK261439 Permatage Flowable, Settable Hemostatic Bone PasteOrthocon, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K791495 | Lukens Bone Wax (Gamma Radiation) | Lukens Corp. | 1979 | — |
| −12 | K971680 | Auto Suture Bone Wax | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −11 | K041363 | Aoc Bone Wax | Ceremed, Inc. | 2004 | 1 |
| −10 | K050440 | Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene, Model BW-12 | Ceremed, Inc. | 2005 | — |
| −9 | K052528 | Aoc Bone Wax Ostene, Osteotene and Ceretene | Ceremed, Inc. | 2005 | — |
| −8 | K062280 | Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and Actipaste | Ceremed, Inc. | 2006 | — |
| −7 | K070093 | Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, Actipaste | Ceremed, Inc. | 2007 | — |
| −6 | K082491 | Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene… | Ceremed, Inc. | 2008 | — |
| −5 | K091636 | Ostene CT, Aoc CT, Osteotene, Ceretene | Ceremed, Inc. | 2009 | — |
| −4 | K102071 | Ostene CT, Aoc CT, Osteotene, Ceretene | Ceremed, Inc. | 2010 | — |
| −3 | K141502 | HBP4 Hardening, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2014 | — |
| −2 | K152005 | MONTAGE Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2015 | — |
| −1 | K202363 | HBP7 Settable Hemostatic Bone Putty | Orthocon, Inc. | 2021 | — |
| 0 (this device) | K261439 | Permatage Flowable, Settable Hemostatic Bone Paste | Orthocon, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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 MTJ? 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 MTJ device
- #1 K262769 Permatage XT Settable Nonabsorbable Hemostatic…score 15.5 · 13 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 |
|---|---|---|---|
| * | K202363 | HBP7 Settable Hemostatic Bone PuttySummary page 5…MTJ Regulation: Pre-enactment Predicate Devices: Primary Predicate: Orthocon, Inc. HBP7 Settable Hemostatic Bone Putty [510(k) Number K202363] Reference Device: Orthocon, Inc. Permatage Flowable Settable Bone Paste [510(k) Number K253732] Devi… | 2021 |
| † | K253732 | Permatage Flowable, Settable Bone Paste | 2026 |
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 47 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 21 ancestors have a recall of any class.
- 1 other device also cites its predicate K202363.
How does its category compare?
All MTJ devicesMTJ Wax, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MTJ
4in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MTJ
370in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MTJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MTJ
22in 2025
MAUDE reports naming product code MTJ, 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 | 0 | — | 0 | 2 |
| 2008 | 1 | — | 1 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 5 | 140 | 0 | 2 |
| 2012 | 3 | 141 | 0 | 8 |
| 2013 | 2 | — | 0 | 5 |
| 2014 | 4 | 46 | 0 | 6 |
| 2015 | 2 | — | 0 | 11 |
| 2016 | 2 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 12 |
| 2019 | 1 | — | 0 | 17 |
| 2020 | 1 | — | 0 | 16 |
| 2021 | 1 | — | 0 | 12 |
| 2022 | 1 | — | 0 | 31 |
| 2023 | 4 | 370 | 1 | 20 |
| 2024 | 0 | — | 0 | 32 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Orthocon Permatage Flowable, Settable Hemostatic Bone Paste is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.
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/K261439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261439: Permatage Flowable, Settable Hemostatic Bone Paste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261439
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026