510(k) · Cleared
ClearedVitoss Scaffold Synthetic Cancellous Bone Void Filler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthovita Co. · MQV Filler, Bone Void, Calcium Compound
Cleared on Dec 14, 2000 after a 357-day review. The FDA summary names its predicate without a number. 385 later devices descend from it.
- Decided
- Dec 14, 2000
- Review
- 357 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 0
385 later devices descend from it, 26 citing it directly.
- This deviceK994337 Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita Co. · 2000
- Descendant · cites it directly · 142 of its ownK032268 MBCPBiomatlante · 2003
- Descendant · cites it directly · 133 of its ownK030131 Ossatura BCP Bone Void FillerIsotis NV · 2003
- Descendant · 2 generations on · 122 of its ownK043005 Modification to MBCPBiomatlante · 2005
- Descendant · 2 generations on · 113 of its ownK040082 Pore-SI Bone Graft SubstituteApatech, Ltd. · 2004
- Descendant · 3 generations on · 111 of its ownK071206 Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteApatech, Ltd. · 2007 · Recalled
Showing 5 of 385 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 385 · See all- K032268MBCPBiomatlante · 2003 · cites it directly142descendants
- K030131Ossatura BCP Bone Void FillerIsotis NV · 2003 · cites it directly133descendants
- K043005Modification to MBCPBiomatlante · 2005 · 2 generations on122descendants
- K040082Pore-SI Bone Graft SubstituteApatech, Ltd. · 2004 · 2 generations on113descendants
- K071206Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteApatech, Ltd. · 2007 · 3 generations on111descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void Filler | Orthovita Co. | 2000 | — |
| +1 | K032268 | MBCP | Biomatlante | 2003 | — |
| +1 | K030131 | Ossatura BCP Bone Void Filler | Isotis NV | 2003 | — |
| +2 | K043005 | Modification to MBCP | Biomatlante | 2005 | — |
| +2 | K040082 | Pore-SI Bone Graft Substitute | Apatech, Ltd. | 2004 | — |
| +3 | K071206 | Actifuse Abx E-Z-Fil Putty Bone Graft Substitute | Apatech, Ltd. | 2007 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 16 | 0 |
| 2006 | 13 | 0 |
| 2007 | 14 | 0 |
| 2008 | 23 | 0 |
| 2009 | 19 | 0 |
| 2010 | 15 | 0 |
| 2011 | 9 | 0 |
| 2012 | 10 | 0 |
| 2013 | 6 | 0 |
| 2014 | 19 | 0 |
| 2015 | 13 | 0 |
| 2016 | 8 | 0 |
| 2017 | 12 | 0 |
| 2018 | 17 | 0 |
| 2019 | 11 | 0 |
| 2020 | 17 | 0 |
| 2021 | 13 | 0 |
| 2022 | 16 | 0 |
| 2023 | 28 | 0 |
| 2024 | 39 | 0 |
| 2025 | 29 | 0 |
| 2026 | 19 | 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 |
|---|---|---|---|
| * | — | Pro Osteon 500R Resorbable Bone Void Filler Named without a submission number |
What descends from it? (385)
See all 38526 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032268 | MBCP | 2003 | 142 |
| K030131 | Ossatura BCP Bone Void Filler | 2003 | 133 |
| K012751 | Healos Bone Graft Material | 2001 | 84 |
| K090641 | Curios | 2009 | 79 |
| K061499 | Osferion | 2007 | 73 |
| K033679 | Copsios Bone Void Filler (BVF) | 2004 | 54 |
| K031817 | Cellplex TCP Synthetic Cancellous Bone | 2003 | 52 |
| K032130 | Vitoss-Filled Cartridge | 2003 | 50 |
| K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive… | 2008 | 47 |
| K021963 | Biosorb Resorbable Void Filler | 2003 | 21 |
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, K032268 (Biomatlante, 2003) has gone furthest, with 142 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 Synthetic Cancellous Bone Void Filler is intended only for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Scaffold is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Scaffold should not be used to treat large defects that in the surgeon’s opinion would fail to heal spontaneously.…
Read the full statement (121 words)
Vitoss Scaffold Synthetic Cancellous Bone Void Filler is intended only for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Scaffold is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Scaffold should not be used to treat large defects that in the surgeon’s opinion would fail to heal spontaneously.
Vitoss Scaffold is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994337: Vitoss Scaffold Synthetic Cancellous Bone Void Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994337
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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