510(k) · Cleared
ClearedVitoss Scaffold Foam Bone Graft Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthovita, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Dec 19, 2003 after a 148-day review. The FDA summary names its predicate without a number. 123 later devices descend from it.
- Decided
- Dec 19, 2003
- Review
- 148 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 0
123 later devices descend from it, 17 citing it directly.
- This deviceK032288 Vitoss Scaffold Foam Bone Graft MaterialOrthovita, Inc. · 2003
- Descendant · cites it directly · 59 of its ownK051386 Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005
- Descendant · cites it directly · 51 of its ownK072184 Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007
- Descendant · 2 generations on · 50 of its ownK081439 Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008
- Descendant · cites it directly · 47 of its ownK083033 Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister…Orthovita, Inc. · 2008
- Descendant · cites it directly · 47 of its ownK071813 Mastergraft PuttyMedtronic Sofamor Danek · 2007
Showing 5 of 123 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 123 · See all- K051386Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005 · cites it directly59descendants
- K072184Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007 · cites it directly51descendants
- K081439Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008 · 2 generations on50descendants
- K083033Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive…Orthovita, Inc. · 2008 · cites it directly47descendants
- K071813Mastergraft PuttyMedtronic Sofamor Danek · 2007 · cites it directly47descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032288 | Vitoss Scaffold Foam Bone Graft Material | Orthovita, Inc. | 2003 | — |
| +1 | K051386 | Mastergraft Putty Bone Void Filler | Medtronic Vascular | 2005 | — |
| +1 | K072184 | Vitoss Bioactive Foam Bone Graft Substitute | Orthovita, Inc. | 2007 | — |
| +2 | K081439 | Vitoss Bioactive Foam Pack Bone Graft Substitute | Orthovita, Inc. | 2008 | — |
| +1 | K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam &… | Orthovita, Inc. | 2008 | — |
| +1 | K071813 | Mastergraft Putty | Medtronic Sofamor Danek | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 7 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 10 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 7 | 0 |
| 2018 | 7 | 0 |
| 2019 | 4 | 0 |
| 2020 | 7 | 0 |
| 2021 | 3 | 0 |
| 2022 | 7 | 0 |
| 2023 | 8 | 0 |
| 2024 | 12 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | — | Vitoss Scaffold Synthetic Cancellous Bone Void Filler Named without a submission number | |
| * | — | Healos Bone Graft Material Named without a submission number |
What descends from it? (123)
See all 12317 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051386 | Mastergraft Putty Bone Void Filler | 2005 | 59 |
| K072184 | Vitoss Bioactive Foam Bone Graft Substitute | 2007 | 51 |
| K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive… | 2008 | 47 |
| K071813 | Mastergraft Putty | 2007 | 47 |
| K063124 | Integra Mozaik Bone Regeneration Matrix - Strips | 2007 | 40 |
| K052812 | Ossimend (TM) Bone Graft Material | 2006 | 40 |
| K050789 | Formagraft Collagen Bone Graft Matrix | 2005 | 11 |
| K081558 | Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CC | 2008 | 10 |
| K091031 | Pioneer Surgical Nanoss BVF-E | 2009 | 7 |
| K142276 | MCS Bone Graft | 2015 | 3 |
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?
- Of its descendants, K051386 (Medtronic Vascular, 2005) has gone furthest, with 59 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.
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?
Vitoss Scaffold Foam Bone Graft Material is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Scaffold Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Scaffold Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. Vitoss…
Read the full statement (123 words)
Vitoss Scaffold Foam Bone Graft Material is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Scaffold Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Scaffold Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Vitoss Scaffold Foam Bone Graft Material is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032288: Vitoss Scaffold Foam Bone Graft Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032288
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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