510(k) · Cleared
ClearedVitoss Bioactive Foam Pack 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 Jun 17, 2008 as substantially equivalent to K072184 (Orthovita, Inc., 2007) after a 26-day review. Its family tree reaches back 5 generations to 1996. 50 later devices descend from it.
- Decided
- Jun 17, 2008
- Review
- 26 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K960978 (1996). 14 ancestors in all. 50 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 4 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 3 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 2 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 1 generation backK072184 Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007
- This deviceK081439 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
- Descendant · cites it directly · 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 · cites it directly17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −4 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −3 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −2 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −1 | K072184 | Vitoss Bioactive Foam Bone Graft Substitute | Orthovita, Inc. | 2007 | — |
| 0 (this device) | 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 | — |
| +1 | K103173 | Vitoss BA Bimodal Bioactive Bone Graft Substitute | Orthovita, Inc. | 2011 | — |
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 | 1 | 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? (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 |
|---|---|---|---|
| * | K072184 | Vitoss Bioactive Foam Bone Graft SubstituteSummary page 1…Graft Substitute Classification Name - Bone Void Filler Product Code - MQV Predicate Devices Orthovita, Inc. - Vitoss Bioactive Foam Bone Graft Substitute (K072 184) Intended Use / Indications for Use Vitoss® Bioactive Foam Bone Graft Substitute- STRIP and PACK are labeled with the following… | 2007 |
What descends from it? (50)
See all 506 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive… | 2008 | 47 |
| K103173 | Vitoss BA Bimodal Bioactive Bone Graft Substitute | 2011 | 17 |
| K163621 | Vitoss Bioactive (BA) Injectable | 2017 | 2 |
| K102545 | FM-02 Bone Graft Substitute | 2010 | 2 |
| K111944 | NB3D Bone Void Filler | 2011 | 1 |
| K090387 | Kainos+ | 2009 | 0 |
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 12 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K083033 (Orthovita, Inc., 2008) has gone furthest, with 47 descendants of its own.
- 3 other devices also cite its predicate K072184.
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. 2008, 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 Bone Graft Substitute 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…
Read the full statement (126 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 Bone Graft Substitute 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/K081439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081439: Vitoss Bioactive Foam Pack Bone Graft Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081439
Report an extraction error
Are you the manufacturer?
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