510(k) · Cleared
ClearedVitoss-Filled Cartridge
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 Nov 5, 2003 as substantially equivalent to K994337 (Orthovita Co., 2000) and 1 other predicate after a 117-day review. Its family tree reaches back 1 generation to 2000. 50 later devices descend from it.
- Decided
- Nov 5, 2003
- Review
- 117 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K994337 (2000). 2 ancestors in all. 50 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK994337 Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita Co. · 2000
- This deviceK032130 Vitoss-Filled CartridgeOrthovita, Inc. · 2003
- Descendant · cites it directly · 47 of its ownK083033 Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister…Orthovita, Inc. · 2008
- Descendant · 2 generations on · 25 of its ownK090855 Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009
- Descendant · 2 generations on · 22 of its ownK091607 Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp. · 2009
- Descendant · 3 generations on · 21 of its ownK093447 CarrigenEtex Corp. · 2010
- Descendant · 2 generations on · 17 of its ownK103173 Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc. · 2011
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K083033Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive…Orthovita, Inc. · 2008 · cites it directly47descendants
- K090855Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009 · 2 generations on25descendants
- K091607Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp. · 2009 · 2 generations on22descendants
- K093447CarrigenEtex Corp. · 2010 · 3 generations on21descendants
- K103173Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc. · 2011 · 2 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void Filler | Orthovita Co. | 2000 | — |
| 0 (this device) | K032130 | Vitoss-Filled Cartridge | Orthovita, Inc. | 2003 | — |
| +1 | K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam &… | Orthovita, Inc. | 2008 | — |
| +2 | K090855 | Equivabone Osteoinductive Bone Graft Substitute | Etex Corp. | 2009 | — |
| +2 | K091607 | Alpha-BSM, Beta-BSM, Gamma-BSM, Equivabone | Etex Corp. | 2009 | — |
| +3 | K093447 | Carrigen | Etex Corp. | 2010 | — |
| +2 | K103173 | Vitoss BA Bimodal Bioactive Bone Graft Substitute | Orthovita, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void FillerSummary page 1…and Piston Device Description: The Vitoss-Filled Cartridge is a device that combines two Orthovita products, Vitoss Scaffold Synthetic Cancellous Bone Void Filler (K994337) and the Imbibe I1 Syringe (K030208) into a kit configuration. The convenience kit provides the Imbibe I1 Syringe loaded (fille… | 2000 |
| * | K030208 | Imbibe II SyringeSummary page 1…he Vitoss-Filled Cartridge is a device that combines two Orthovita products, Vitoss Scaffold Synthetic Cancellous Bone Void Filler (K994337) and the Imbibe I1 Syringe (K030208) into a kit configuration. The convenience kit provides the Imbibe I1 Syringe loaded (filled) with Vitoss Scaffold and an empty… | 2003 |
What descends from it? (50)
See all 503 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?
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 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 resulting from traumatic injury to the bone. VITOSS should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. VITOSS…
Read the full statement (175 words)
VITOSS@Scaffold Synthetic Cancellous Bone Void Filler 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 is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. VITOSS 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 packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
The VITOSS-Filled Cartridge is intended for use as a piston syringe system for the aspiration of autogenous blood and/or bone marrow. This Cartridge provides the surgeon with a convenient way to mix autologous blood or bone marrow with Vitoss Scaffold@and deliver the material to the orthopaedic surgical site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032130: Vitoss-Filled Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032130
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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