510(k) · Cleared
ClearedMastergraft Strip; Mastergraft Ultramatrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Apr 19, 2013 as substantially equivalent to K082166 (Medtronic Sofamor Danek, 2009) after a 67-day review. Its family tree reaches back 8 generations to 1996. 2 later devices descend from it.
- Decided
- Apr 19, 2013
- Review
- 67 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K960978 (1996). 33 ancestors in all, the oldest K871773 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 7 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 6 generations backK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
- 5 generations backK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
- 4 generations backK043308 Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005
- 3 generations backK051386 Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005
- 2 generations backK071813 Mastergraft PuttyMedtronic Sofamor Danek · 2007
- 1 generation backK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
- This deviceK130335 Mastergraft Strip; Mastergraft UltramatrixMedtronic Sofamor Danek USA, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK151172 MASTERGRAFT ContainMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK141824 Mastergraft Matrix Ext; Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −7 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −6 | K000515 | Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101… | Interpore Cross Intl. | 2000 | — |
| −5 | K012751 | Healos Bone Graft Material | Orquest, Inc. | 2001 | — |
| −4 | K043308 | Modification to: Healos Bone Graft Material | Depuy Spine, Inc. | 2005 | — |
| −3 | K051386 | Mastergraft Putty Bone Void Filler | Medtronic Vascular | 2005 | — |
| −2 | K071813 | Mastergraft Putty | Medtronic Sofamor Danek | 2007 | — |
| −1 | K082166 | Mastergraft Strip | Medtronic Sofamor Danek | 2009 | — |
| 0 (this device) | K130335 | Mastergraft Strip; Mastergraft Ultramatrix | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| +1 | K151172 | MASTERGRAFT Contain | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +1 | K141824 | Mastergraft Matrix Ext; Mastergraft Putty, Mastergraft Strip | Medtronic Sofamor Danek, Inc. | 2014 | — |
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 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K082166 | Mastergraft StripSummary page 1…8.3045 CLASSIFICATION PRODUCT CODE: MQV CLASS: 11 I11. IDENTIFICATION OF LEGALLY MARKETED DEVICES: MASTERGRAFT® Strip K082 166 (S.E. 06/02/2009) IV. DEVICE DESCRIPTION: MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix consist of a combination of… | 2009 |
What descends from it? (2)
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 17 years and passes through 8 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 33 ancestors have a recall of any class.
- Of its descendants, K151172 (Medtronic Sofamor Danek USA, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K082166.
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. 2013, 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?
MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix are to be combined with
autogenous bone marrow and are indicated for bony voids or gaps that are not intrinsic to the
stability of the bony structure and can be used as a bone graft extender.
The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the
posterolateral spine, pelvis, ilium, and/or extremities). 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130335 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130335: Mastergraft Strip; Mastergraft Ultramatrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130335
Report an extraction error
Are you the manufacturer?
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