510(k) · Cleared
ClearedMastergraft Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Apr 22, 2003 as substantially equivalent to K020986 (Medtronic Sofamor Danek, Inc., 2002) and 1 other predicate after a 181-day review. Its family tree reaches back 2 generations to 1999. 39 later devices descend from it.
- Decided
- Apr 22, 2003
- Review
- 181 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K990131 (1999). 3 ancestors in all. 39 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 1 generation backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
- This deviceK023553 Mastergraft MatrixMedtronic Sofamor Danek, Inc. · 2003
- Descendant · cites it directly · 38 of its ownK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
- Descendant · 2 generations on · 30 of its ownK140375 Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014
- Descendant · 3 generations on · 6 of its ownK181225 AltaporeBaxter Healthcare Corporation · 2018
- Descendant · 3 generations on · 4 of its ownK193075 Osteo3 ZP PuttySirakoss, Ltd. · 2020
- Descendant · 3 generations on · 4 of its ownK192363 AltaporeBaxter Healthcare Corporation · 2020
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K082166Mastergraft StripMedtronic Sofamor Danek · 2009 · cites it directly38descendants
- K140375Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014 · 2 generations on30descendants
- K181225AltaporeBaxter Healthcare Corporation · 2018 · 3 generations on6descendants
- K193075Osteo3 ZP PuttySirakoss, Ltd. · 2020 · 3 generations on4descendants
- K192363AltaporeBaxter Healthcare Corporation · 2020 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| −1 | K020986 | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | 2002 | — |
| 0 (this device) | K023553 | Mastergraft Matrix | Medtronic Sofamor Danek, Inc. | 2003 | — |
| +1 | K082166 | Mastergraft Strip | Medtronic Sofamor Danek | 2009 | — |
| +2 | K140375 | Mastergraft Putty, Mastergraft Strip | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| +3 | K181225 | Altapore | Baxter Healthcare Corporation | 2018 | — |
| +3 | K193075 | Osteo3 ZP Putty | Sirakoss, Ltd. | 2020 | — |
| +3 | K192363 | Altapore | Baxter Healthcare Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 7 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K020986 | Mastergraft Resorbable Ceramic Our reading of the summary gave K020956, FDA’s number for Vivosonic Dianostic Ultrasound Imaging Coupling Media (Microtek Medical, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “MasterGraft Resorbable Ceramic”. | 2002 |
| * | K012506 | Mastergraft Resorbable Ceramic GranulesSummary page 1…ion was provided which demnmstrated MasterGraftTMMatrix to be substmtially equivalent to the previously cleared MasterGrafP Resorbable Ceranlic (K0209S6and K012506). (3 ‘).h, DEPARTMENT OF HEALTH gL HUMAN SERVICES Public Healt… | 2002 |
What descends from it? (39)
See all 391 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082166 | Mastergraft Strip | 2009 | 38 |
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 4 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K082166 (Medtronic Sofamor Danek, 2009) has gone furthest, with 38 descendants of its own.
- 8 other devices also cite its predicate K020986.
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.
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?
MasterGraftTMMatrix combined with autogenous bone marrow is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraftTM Matrix is to be gently packed into bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MasterGraftTM Matrix provides a bone void filler that resorbs and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023553 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023553: Mastergraft Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023553
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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