510(k) · Cleared
ClearedMontage-XT Settable Bone Putty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthocon, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Nov 18, 2024 as substantially equivalent to K242050 (Orthocon, Inc., 2024) and 3 other predicates after a 6-day review. Its family tree reaches back 14 generations to 1979.
- Decided
- Nov 18, 2024
- Review
- 6 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K791495 (1979). 77 ancestors in all. No later device cites it as a predicate yet.
- Root · 14 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
- 10 generations between
- 3 generations backK152005 MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2015
- 2 generations backK213418 MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2023
- 1 generation backK232998 Montage- XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2023
- This deviceK243506 Montage-XT Settable Bone PuttyOrthocon, Inc. · 2024
Show all 14 generations
- Root · 14 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
- 13 generations backK971680 Auto Suture Bone WaxUnited States Surgical, A Division of Tyco Healthc · 1997
- 12 generations backK041363 Aoc Bone WaxCeremed, Inc. · 2004 · Recalled
- 11 generations backK050440 Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene…Ceremed, Inc. · 2005
- 10 generations backK052528 Aoc Bone Wax Ostene, Osteotene and CereteneCeremed, Inc. · 2005
- 9 generations backK062280 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and…Ceremed, Inc. · 2006
- 8 generations backK070093 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, ActipasteCeremed, Inc. · 2007
- 7 generations backK082491 Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc…Ceremed, Inc. · 2008
- 6 generations backK091636 Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc. · 2009
- 5 generations backK102071 Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc. · 2010
- 4 generations backK141502 HBP4 Hardening, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2014
- 3 generations backK152005 MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2015
- 2 generations backK213418 MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2023
- 1 generation backK232998 Montage- XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2023
- This deviceK243506 Montage-XT Settable Bone PuttyOrthocon, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K791495 | Lukens Bone Wax (Gamma Radiation) | Lukens Corp. | 1979 | — |
| −13 | K971680 | Auto Suture Bone Wax | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −12 | K041363 | Aoc Bone Wax | Ceremed, Inc. | 2004 | 1 |
| −11 | K050440 | Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene, Model BW-12 | Ceremed, Inc. | 2005 | — |
| −10 | K052528 | Aoc Bone Wax Ostene, Osteotene and Ceretene | Ceremed, Inc. | 2005 | — |
| −9 | K062280 | Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and Actipaste | Ceremed, Inc. | 2006 | — |
| −8 | K070093 | Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, Actipaste | Ceremed, Inc. | 2007 | — |
| −7 | K082491 | Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene… | Ceremed, Inc. | 2008 | — |
| −6 | K091636 | Ostene CT, Aoc CT, Osteotene, Ceretene | Ceremed, Inc. | 2009 | — |
| −5 | K102071 | Ostene CT, Aoc CT, Osteotene, Ceretene | Ceremed, Inc. | 2010 | — |
| −4 | K141502 | HBP4 Hardening, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2014 | — |
| −3 | K152005 | MONTAGE Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2015 | — |
| −2 | K213418 | MONTAGE Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2023 | — |
| −1 | K232998 | Montage- XT Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2023 | — |
| 0 (this device) | K243506 | Montage-XT Settable Bone Putty | Orthocon, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 8 | 0 |
| 2002 | 9 | 0 |
| 2003 | 7 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 MQV? 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 MQV device
- #1 K232315 Catalyst Bone Void Fillerscore 25.2 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K242050 | Montage Settable Bone PuttySummary page 6…1 Primary Predicate Device: Orthocon, Inc. MONTAGE Settable Bone Putty 510(k) K242050 Additional Predicate Devices: Orthocon, Inc. MONTAGE-XT Settable, Resorbable Bone Putty 510(k) K233566 Orthocon, Inc. MONTAGE… | 2024 |
| * | K233566 | Montage-XT Settable, Resorbable Bone PuttySummary page 6…cate Device: Orthocon, Inc. MONTAGE Settable Bone Putty 510(k) K242050 Additional Predicate Devices: Orthocon, Inc. MONTAGE-XT Settable, Resorbable Bone Putty 510(k) K233566 Orthocon, Inc. MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty 510(k) K232998 Orthocon, Inc. MONTAGE-XT Settable, Resorba… | 2024 |
| * | K232998 | Montage- XT Settable, Resorbable Hemostatic Bone PuttySummary page 6…Predicate Devices: Orthocon, Inc. MONTAGE-XT Settable, Resorbable Bone Putty 510(k) K233566 Orthocon, Inc. MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty 510(k) K232998 Orthocon, Inc. MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty 510(k) K220315 Device Description: MONTAGE-XT Settable B… | 2023 |
| * | K220315 | MONTAGE-XT Settable, Resorbable Hemostatic Bone PuttySummary page 6…K233566 Orthocon, Inc. MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty 510(k) K232998 Orthocon, Inc. MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty 510(k) K220315 Device Description: MONTAGE-XT Settable Bone Putty is a sterile, biocompatible, resorbable material for use in the control of… | 2022 |
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 45 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 77 ancestors have a recall of any class.
How does its category compare?
All MQV devicesMQV Filler, Bone Void, Calcium Compound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MQV
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQV
57in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQV
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQV
57in 2025
MAUDE reports naming product code MQV, 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 | 35 | 144 | 5 | 67 |
| 2008 | 32 | 102 | 3 | 71 |
| 2009 | 23 | 180 | 1 | 81 |
| 2010 | 17 | 147 | 0 | 68 |
| 2011 | 16 | 92 | 6 | 114 |
| 2012 | 9 | 107 | 3 | 149 |
| 2013 | 12 | 197 | 2 | 223 |
| 2014 | 20 | 153 | 0 | 111 |
| 2015 | 18 | 184 | 0 | 125 |
| 2016 | 8 | 214 | 1 | 106 |
| 2017 | 17 | 124 | 1 | 107 |
| 2018 | 23 | 124 | 2 | 86 |
| 2019 | 13 | 90 | 0 | 65 |
| 2020 | 15 | 132 | 1 | 126 |
| 2021 | 8 | 88 | 0 | 101 |
| 2022 | 9 | 118 | 0 | 47 |
| 2023 | 21 | 74 | 3 | 120 |
| 2024 | 28 | 55 | 2 | 68 |
| 2025 | 14 | 57 | 1 | 57 |
| 2026 | 5 | 96 | 4 | — |
What is it indicated for?
Montage-XT Settable Bone Putty is indicated for use on the sternum in cardiothoracic surgery following sternotomy to control bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade, as well as to fill bony voids or gaps in the sternum. When hardened in situ, Montage-XT may be used on the sternum to augment hardware to help support bone during the cardiothoracic surgical procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243506: Montage-XT Settable Bone Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243506
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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