510(k) · Cleared
Recalled · Class II · 2011Integra Mozaik Bone Regeneration Matrix - Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Lifesciences Corp. · MQV Filler, Bone Void, Calcium Compound
Cleared on Jan 19, 2007 as substantially equivalent to K032288 (Orthovita, Inc., 2003) after a 98-day review. Its family tree reaches back 1 generation to 2003. 40 later devices descend from it. It has been recalled once.
- Decided
- Jan 19, 2007
- Review
- 98 days
- Class
- Class II
- Product code
- MQV
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032288 (2003). 40 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK032288 Vitoss Scaffold Foam Bone Graft MaterialOrthovita, Inc. · 2003
- This deviceK063124 Integra Mozaik Bone Regeneration Matrix - StripsIntegra Lifesciences Corp. · 2007
- 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 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · 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 |
|---|---|---|---|---|---|
| −1 | K032288 | Vitoss Scaffold Foam Bone Graft Material | Orthovita, Inc. | 2003 | — |
| 0 (this device) | K063124 | Integra Mozaik Bone Regeneration Matrix - Strips | Integra Lifesciences Corp. | 2007 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 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? (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 |
|---|---|---|---|
| * | K032288 | Vitoss Scaffold Foam Bone Graft MaterialSummary page 1…lly equivalent in function and intended use to VITOSS® Scaffold Foam Bone Graft Matrix which has been cleared to market under Premarket Notification 510(k) K032288. Device Description: The Integra MOZAIKT M Osteoconductive Scaffold - Strip is a resorbable bone void filler made f… | 2003 |
What descends from it? (40)
See all 403 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 11, 2011 | Class II | Z-1795-2012 | Employee error | The Instructions for Use {IFU} {Putty Part Number 7700713001 and Strip Part Number 770151300l for CE marked Mozaik Strip and Putty products contains an incorrect translation of the term "bone marrow aspirate". The term is incorrectly… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2007, 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?
The Integra MOZAIK Osteoconductive Scaffold - Strip is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine, and pelvis not intrinsic to the stability of the bony structure. Integra MOZAIK Strip is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bony void or gap (defect), Integra MOZAIK Strip is resorbed and replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063124: Integra Mozaik Bone Regeneration Matrix - Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063124
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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