510(k) · Cleared
ClearedMontage 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 Jul 29, 2024 as substantially equivalent to K222063 (Orthocon, Inc., 2023) and 3 other predicates after a 17-day review. Its family tree reaches back 13 generations to 1979. 1 later device descends from it.
- Decided
- Jul 29, 2024
- Review
- 17 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K791495 (1979). 73 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 backK213418 MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2023
- This deviceK242050 Montage Settable Bone PuttyOrthocon, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK243506 Montage-XT Settable Bone PuttyOrthocon, Inc. · 2024
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 backK213418 MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2023
- This deviceK242050 Montage Settable Bone PuttyOrthocon, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K243506Montage-XT Settable Bone PuttyOrthocon, Inc. · 2024 · cites it directly0descendants
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 | K213418 | MONTAGE Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2023 | — |
| 0 (this device) | K242050 | Montage Settable Bone Putty | Orthocon, Inc. | 2024 | — |
| +1 | 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 |
| 2023 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 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 |
|---|---|---|---|
| * | K222063 | MONTAGE Settable, Resorbable Bone PuttySummary page 6…1/2 Primary Predicate Device: Orthocon, Inc. MONTAGE Settable, Resorbable Bone Putty 510(k) K222063 Additional Predicate Devices: Orthocon, Inc. MONTAGE Settable, Resorbable Hemostatic Bone Putty 510(k) K213418 Orthoco… | 2023 |
| * | K213418 | MONTAGE Settable, Resorbable Hemostatic Bone PuttySummary page 6…MONTAGE Settable, Resorbable Bone Putty 510(k) K222063 Additional Predicate Devices: Orthocon, Inc. MONTAGE Settable, Resorbable Hemostatic Bone Putty 510(k) K213418 Orthocon, Inc. MONTAGE Settable, Resorbable Hemostatic Bone Putty 510(k) K152005 Orthocon, Inc. HBP4 Hardening,… | 2023 |
| * | K152005 | MONTAGE Settable, Resorbable Hemostatic Bone PuttySummary page 6…rthocon, Inc. MONTAGE Settable, Resorbable Hemostatic Bone Putty 510(k) K213418 Orthocon, Inc. MONTAGE Settable, Resorbable Hemostatic Bone Putty 510(k) K152005 Orthocon, Inc. HBP4 Hardening, Resorbable Hemostatic Bone Putty 510(k) K141502 Device Description: MONTAGE Settable B… | 2015 |
| * | K141502 | HBP4 Hardening, Resorbable Hemostatic Bone PuttySummary page 6…Orthocon, Inc. MONTAGE Settable, Resorbable Hemostatic Bone Putty 510(k) K152005 Orthocon, Inc. HBP4 Hardening, Resorbable Hemostatic Bone Putty 510(k) K141502 Device Description: MONTAGE Settable Bone Putty is a sterile, biocompatible, resorbable material for use in the control of ble… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243506 | Montage-XT Settable Bone Putty | 2024 | 0 |
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 73 ancestors have a recall of any class.
- Of its descendants, K243506 (Orthocon, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K222063.
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 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 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/K242050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242050: Montage 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/K242050
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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