510(k) · Cleared
ClearedIntegra Mozaik and OS Moldable Morsels
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra LifeSciences Corporation · MQV Filler, Bone Void, Calcium Compound
Cleared on Dec 4, 2009 as substantially equivalent to K062353 (Integra LifeSciences Corporation, 2006) after a 214-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Dec 4, 2009
- Review
- 214 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K032288 (2003). No later device cites it as a predicate yet.
- Root · 2 generations backK032288 Vitoss Scaffold Foam Bone Graft MaterialOrthovita, Inc. · 2003
- 1 generation backK062353 Mozaik Bone Regeneration Matrix - PuttyIntegra LifeSciences Corporation · 2006 · Recalled
- This deviceK091302 Integra Mozaik and OS Moldable MorselsIntegra LifeSciences Corporation · 2009
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K062353 | Mozaik Bone Regeneration Matrix - PuttySummary page 1…rsels and Integra OS Moldable Morsels are substantially equivalent in function and intended use to the currently marketed Integra MOZAIK Ostecondcutive Scaffold - Putty (K062353). Intended Use: Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels combined with bone marrow aspirate, are intended… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K062353.
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. 2009, 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 Moldable Morsels and Integra OS Moldable Morsels, combined with bone marrow aspirate, are intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine (posterolateral spinal fusions only), and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels are also indicated for use in the treatment of surgically treated…
Read the full statement (112 words)
The Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels, combined with bone marrow aspirate, are intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine (posterolateral spinal fusions only), and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels are also indicated for use in the treatment of surgically treated osseous defects or osseouIs defects created from traumatic injury to the bone. Following placement in the bony void or gap (defect), Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels are resorbed and replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091302: Integra Mozaik and OS Moldable Morsels.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091302
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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