510(k) · Cleared
ClearedMontage-XT Settable, Resorbable 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 Aug 21, 2024 as substantially equivalent to K222063 (Orthocon, Inc., 2023) after a 289-day review. Its family tree reaches back 11 generations to 2002. 1 later device descends from it.
- Decided
- Aug 21, 2024
- Review
- 289 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K013966 (2002). 46 ancestors in all, the oldest K861369 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
- 7 generations between
- 3 generations backK141245 Etex Mixing and Delivery SystemEtex Corporation · 2014
- 2 generations backK161447 HydroSet XTOrthovita, Inc. · 2016 · Recalled
- 1 generation backK222063 MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc. · 2023
- This deviceK233566 Montage-XT Settable, Resorbable Bone PuttyOrthocon, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK243506 Montage-XT Settable Bone PuttyOrthocon, Inc. · 2024
Show all 11 generations
- Root · 11 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
- 10 generations backK022629 WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc · 2002
- 9 generations backK031817 Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc · 2003
- 8 generations backK043261 Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 2005 · Recalled
- 7 generations backK100754 Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
- 6 generations backK111632 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011
- 5 generations backK121476 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012
- 4 generations backK133021 Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014
- 3 generations backK141245 Etex Mixing and Delivery SystemEtex Corporation · 2014
- 2 generations backK161447 HydroSet XTOrthovita, Inc. · 2016 · Recalled
- 1 generation backK222063 MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc. · 2023
- This deviceK233566 Montage-XT Settable, Resorbable 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 |
|---|---|---|---|---|---|
| −11 | K013966 | Apatight-TCP Bone Graft Substitute | Cerabio, LLC | 2002 | — |
| −10 | K022629 | WMT-TCP Bone Graft Substitute | Wrightmedicaltechnologyinc | 2002 | — |
| −9 | K031817 | Cellplex TCP Synthetic Cancellous Bone | Wrightmedicaltechnologyinc | 2003 | — |
| −8 | K043261 | Harvest Graft Delivery Syringe | Harvest Technologies, Corp. | 2005 | 2 |
| −7 | K100754 | Graft Delivery System Model SA-6115 | Micromedics, Inc. | 2010 | — |
| −6 | K111632 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2011 | — |
| −5 | K121476 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2012 | — |
| −4 | K133021 | Mixing Syringe System | Zimmer Knee Creations, Inc. | 2014 | — |
| −3 | K141245 | Etex Mixing and Delivery System | Etex Corporation | 2014 | — |
| −2 | K161447 | HydroSet XT | Orthovita, Inc. | 2016 | 2 |
| −1 | K222063 | MONTAGE Settable, Resorbable Bone Putty | Orthocon, Inc. | 2023 | — |
| 0 (this device) | K233566 | Montage-XT Settable, Resorbable 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 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K222063 | MONTAGE Settable, Resorbable Bone PuttySummary page 5…Class II Product Code: MQV, OIS Primary Predicate Device: Orthocon, Inc. MONTAGEÒ Settable, Resorbable Bone Putty 510(k) K222063 Reference Predicate Device: Orthocon, Inc. MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty 510(k… | 2023 |
| † | K220315 | MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty | 2022 |
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 22 years and passes through 9 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 46 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?
Orthocon Montage-XT Settable, Resorbable Bone Putty is indicated to fill bony voids or gaps in the skeletal system (i.e., extremities and pelvis). These defects may be surgically created, or osseous defects created as the result of traumatic injury to the bone. Montage-XT is indicated only for filling bony voids or gaps that are not intrinsic to the integrity of the bony structure. When hardened in situ, Montage-XT may be used to augment provisional…
Read the full statement (131 words)
Orthocon Montage-XT Settable, Resorbable Bone Putty is indicated to fill bony voids or gaps in the skeletal system (i.e., extremities and pelvis). These defects may be surgically created, or osseous defects created as the result of traumatic injury to the bone. Montage-XT is indicated only for filling bony voids or gaps that are not intrinsic to the integrity of the bony structure.
When hardened in situ, Montage-XT may be used to augment provisional hardware (e.g., k-wires, plates and screws) and to help support bone fragments during the surgical procedure. The hardened putty acts only as a temporary support medium and is not intended to provide structural support during the healing process.
Montage-XT can be drilled and tapped, and hardware can be placed through it at any time during the setting process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233566: Montage-XT Settable, Resorbable 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/K233566
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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