510(k) · Cleared
ClearedMONTAGE 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 Feb 3, 2023 as substantially equivalent to K161447 (Orthovita, Inc., 2016) after a 205-day review. Its family tree reaches back 10 generations to 2002. 3 later devices descend from it.
- Decided
- Feb 3, 2023
- Review
- 205 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K013966 (2002). 45 ancestors in all, the oldest K861369 (1986). 3 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
- 6 generations between
- 3 generations backK133021 Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014
- 2 generations backK141245 Etex Mixing and Delivery SystemEtex Corporation · 2014
- 1 generation backK161447 HydroSet XTOrthovita, Inc. · 2016 · Recalled
- This deviceK222063 MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK233566 Montage-XT Settable, Resorbable Bone PuttyOrthocon, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK242050 Montage Settable Bone PuttyOrthocon, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK243506 Montage-XT Settable Bone PuttyOrthocon, Inc. · 2024
Show all 10 generations
- Root · 10 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
- 9 generations backK022629 WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc · 2002
- 8 generations backK031817 Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc · 2003
- 7 generations backK043261 Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 2005 · Recalled
- 6 generations backK100754 Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
- 5 generations backK111632 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011
- 4 generations backK121476 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012
- 3 generations backK133021 Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014
- 2 generations backK141245 Etex Mixing and Delivery SystemEtex Corporation · 2014
- 1 generation backK161447 HydroSet XTOrthovita, Inc. · 2016 · Recalled
- This deviceK222063 MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K013966 | Apatight-TCP Bone Graft Substitute | Cerabio, LLC | 2002 | — |
| −9 | K022629 | WMT-TCP Bone Graft Substitute | Wrightmedicaltechnologyinc | 2002 | — |
| −8 | K031817 | Cellplex TCP Synthetic Cancellous Bone | Wrightmedicaltechnologyinc | 2003 | — |
| −7 | K043261 | Harvest Graft Delivery Syringe | Harvest Technologies, Corp. | 2005 | 2 |
| −6 | K100754 | Graft Delivery System Model SA-6115 | Micromedics, Inc. | 2010 | — |
| −5 | K111632 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2011 | — |
| −4 | K121476 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2012 | — |
| −3 | K133021 | Mixing Syringe System | Zimmer Knee Creations, Inc. | 2014 | — |
| −2 | K141245 | Etex Mixing and Delivery System | Etex Corporation | 2014 | — |
| −1 | K161447 | HydroSet XT | Orthovita, Inc. | 2016 | 2 |
| 0 (this device) | K222063 | MONTAGE Settable, Resorbable Bone Putty | Orthocon, Inc. | 2023 | — |
| +1 | K233566 | Montage-XT Settable, Resorbable Bone Putty | Orthocon, Inc. | 2024 | — |
| +1 | K242050 | Montage Settable Bone Putty | Orthocon, Inc. | 2024 | — |
| +2 | 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 | 3 | 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 |
|---|---|---|---|
| * | K161447 | HydroSet XTSummary page 4…er device Classification: Class |l Product code: MQyv, OIS Regulation: 21 CFR 888.3045 Predicate Devices Primary Predicate: Orthovita, Inc. HydroSet XT™ [510(k) Number K161447] Reference Devices: Orthocon, Inc. MONTAGE Settable, Resorbable Hemostatic Bone Putty [510(k) Number K152005] K… | 2016 |
| † | K152005 | MONTAGE Settable, Resorbable Hemostatic Bone Putty | 2015 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 9 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 45 ancestors have a recall of any class.
- Of its descendants, K233566 (Orthocon, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K161447.
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. 2023, 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 Settable, Resorbable Bone Putty is indicated to fill bony voids or gaps in the skeletal system (1.e. extremities and pelvis). These defects may be surgically created, or osseous defects created as the result of traumatic injury to the bone. MONTAGE is indicated only for filling bony voids or gaps that are not itrinsic to the integnity of the bony structure. When hardened in situ, MONTAGE may be used to augment provisional hardware (e.g..…
Read the full statement (131 words)
Orthocon MONTAGE Settable, Resorbable Bone Putty is indicated to fill bony voids or gaps in the skeletal system (1.e. extremities and pelvis). These defects may be surgically created, or osseous defects created as the result of traumatic injury to the bone. MONTAGE is indicated only for filling bony voids or gaps that are not itrinsic to the integnity of the bony structure.
When hardened in situ, MONTAGE 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 1s not intended to provide structural support during the healing process.
MONTAGE can be dnlled and tapped. and hardware can be placed through it at any time duning the setting process.
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/K222063 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222063: MONTAGE 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/K222063
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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