510(k) · Cleared
ClearedVitoss Bioactive Foam Bone Graft Substitute
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 Sep 18, 2007 as substantially equivalent to K032288 (Orthovita, Inc., 2003) and 3 other predicates after a 43-day review. Its family tree reaches back 4 generations to 1996. 51 later devices descend from it.
- Decided
- Sep 18, 2007
- Review
- 43 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K960978 (1996). 13 ancestors in all. 51 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 3 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 2 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 1 generation backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- This deviceK072184 Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007
- Descendant · cites it directly · 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 · 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
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K081439Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008 · cites it directly50descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −3 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −2 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −1 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| 0 (this device) | K072184 | Vitoss Bioactive Foam Bone Graft Substitute | Orthovita, Inc. | 2007 | — |
| +1 | 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 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 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? (4)
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…ft Substitute Classification Name - Bone Void Filler Product Code - MQV Predicate Devices 1. Orthovita, Inc. - Vitoss Scaffold Foam Bone Graft Substitute (K032288) 2. NovaBone - NovaBone Bioactive Synthetic Graft (K052494) 3. NovaBone -NovaBone Putty Bioactive Synthetic Graft (K060728) 4.… | 2003 |
| * | K052494 | Novabone-Bioactive Synthetic GraftSummary page 1…ct Code - MQV Predicate Devices 1. Orthovita, Inc. - Vitoss Scaffold Foam Bone Graft Substitute (K032288) 2. NovaBone - NovaBone Bioactive Synthetic Graft (K052494) 3. NovaBone -NovaBone Putty Bioactive Synthetic Graft (K060728) 4. Nanotherapeutics - Origen DBM with Bioactive Glass (K062459)… | 2005 |
| * | K060728 | Novabone Putty - Bioactive Synthetic GraftSummary page 1…- Vitoss Scaffold Foam Bone Graft Substitute (K032288) 2. NovaBone - NovaBone Bioactive Synthetic Graft (K052494) 3. NovaBone -NovaBone Putty Bioactive Synthetic Graft (K060728) 4. Nanotherapeutics - Origen DBM with Bioactive Glass (K062459) Intended Use / Indications for Use Vitoss® Bioactive Foam Bo… | 2006 |
| * | K062459 | Origen DBM with Bioactive GlassSummary page 1…ne - NovaBone Bioactive Synthetic Graft (K052494) 3. NovaBone -NovaBone Putty Bioactive Synthetic Graft (K060728) 4. Nanotherapeutics - Origen DBM with Bioactive Glass (K062459) Intended Use / Indications for Use Vitoss® Bioactive Foam Bone Graft Substitute is labeled with the following Intended Use st… | 2007 |
What descends from it? (51)
See all 514 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?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K081439 (Orthovita, Inc., 2008) has gone furthest, with 50 descendants of its own.
- 16 other devices also cite its predicate K032288.
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?
Vitoss Bioactive Foam Bone Graft Substitute 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 Bioactive Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Bioactive Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.…
Read the full statement (123 words)
Vitoss Bioactive Foam Bone Graft Substitute 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 Bioactive Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Bioactive Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Vitoss Bioactive Foam Bone Graft Substitute 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/K072184 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072184: Vitoss Bioactive Foam Bone Graft Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072184
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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