510(k) · Cleared
ClearedMineral Collagen Composite Bioactive Extra Moldable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Collagen Matrix, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Aug 2, 2023 as substantially equivalent to K221735 (Collagen Matrix, Inc., 2022) and 1 other predicate after a 33-day review. Its family tree reaches back 11 generations to 1996. 1 later device descends from it.
- Decided
- Aug 2, 2023
- Review
- 33 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K960978 (1996). 51 ancestors in all, the oldest K871773 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 7 generations between
- 3 generations backK140375 Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014
- 2 generations backK182074 Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc. · 2019
- 1 generation backK221735 Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc. · 2022
- This deviceK231942 Mineral Collagen Composite Bioactive Extra MoldableCollagen Matrix, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK240424 Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc. · 2024
Show all 11 generations
- Root · 11 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 10 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 9 generations backK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
- 8 generations backK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
- 7 generations backK043308 Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005
- 6 generations backK051386 Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005
- 5 generations backK071813 Mastergraft PuttyMedtronic Sofamor Danek · 2007
- 4 generations backK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
- 3 generations backK140375 Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014
- 2 generations backK182074 Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc. · 2019
- 1 generation backK221735 Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc. · 2022
- This deviceK231942 Mineral Collagen Composite Bioactive Extra MoldableCollagen Matrix, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −10 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −9 | K000515 | Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101… | Interpore Cross Intl. | 2000 | — |
| −8 | K012751 | Healos Bone Graft Material | Orquest, Inc. | 2001 | — |
| −7 | K043308 | Modification to: Healos Bone Graft Material | Depuy Spine, Inc. | 2005 | — |
| −6 | K051386 | Mastergraft Putty Bone Void Filler | Medtronic Vascular | 2005 | — |
| −5 | K071813 | Mastergraft Putty | Medtronic Sofamor Danek | 2007 | — |
| −4 | K082166 | Mastergraft Strip | Medtronic Sofamor Danek | 2009 | — |
| −3 | K140375 | Mastergraft Putty, Mastergraft Strip | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −2 | K182074 | Mineral Collagen Composite Bioactive Moldable | Collagen Matrix, Inc. | 2019 | — |
| −1 | K221735 | Mineral Collagen Composite Bioactive Moldable | Collagen Matrix, Inc. | 2022 | — |
| 0 (this device) | K231942 | Mineral Collagen Composite Bioactive Extra Moldable | Collagen Matrix, Inc. | 2023 | — |
| +1 | K240424 | Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix | Collagen Matrix, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K221735 | Mineral Collagen Composite Bioactive MoldableSummary page 4…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K221735 Mineral Collagen Composite Bioactive Moldable MQV K1i82074… | 2022 |
| * | K182074 | Mineral Collagen Composite Bioactive MoldableSummary page 5…and the sterility assurance level (SAL 1xA 0-6) remains the same as documented in the primary predicate device submission (K221375) and the predicate device submission (K182074). Pyrogenicity The subject device is non-pyrogenic. There are no changes to the product and the biocompatibility data remains th… | 2019 |
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 |
|---|---|---|---|
| K240424 | Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix | 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 27 years and passes through 9 companies; a new generation was cleared every 2.0 years on median.
- 5 of the 51 ancestors have a recall of any class.
- Of its descendants, K240424 (Collagen Matrix, Inc., 2024) has gone furthest, with 0 descendants of its own.
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?
Mineral Collagen Composite Bioactive Extra Moldable is intended for use as a bone void filler for voids or gaps, that are not intrinsic to the stability of the bony structure. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and…
Read the full statement (115 words)
Mineral Collagen Composite Bioactive Extra Moldable is intended for use as a bone void filler for voids or gaps, that are not intrinsic to the stability of the bony structure. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.
For spine application Mineral Collagen Composite Bioactive Extra Moldable is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231942: Mineral Collagen Composite Bioactive Extra Moldable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231942
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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