510(k) · Cleared
ClearedVitoss Bioactive (BA) Injectable
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 May 2, 2017 as substantially equivalent to K081439 (Orthovita, Inc., 2008) and 3 other predicates after a 131-day review. Its family tree reaches back 8 generations to 1996. 2 later devices descend from it.
- Decided
- May 2, 2017
- Review
- 131 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K960978 (1996). 62 ancestors in all, the oldest K852682 (1985). 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 7 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 6 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 5 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 4 generations backK072184 Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007
- 3 generations backK081439 Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008
- 2 generations backK083033 Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister…Orthovita, Inc. · 2008
- 1 generation backK103173 Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc. · 2011
- This deviceK163621 Vitoss Bioactive (BA) InjectableOrthovita, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK242797 OsteoFlo HydroFiberSurGenTec, LLC · 2024
- Descendant · cites it directly · 0 of its ownK243949 OsteoFlo HydroFiberSurGenTec, LLC · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −7 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −6 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −5 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −4 | K072184 | Vitoss Bioactive Foam Bone Graft Substitute | Orthovita, Inc. | 2007 | — |
| −3 | K081439 | Vitoss Bioactive Foam Pack Bone Graft Substitute | Orthovita, Inc. | 2008 | — |
| −2 | K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam &… | Orthovita, Inc. | 2008 | — |
| −1 | K103173 | Vitoss BA Bimodal Bioactive Bone Graft Substitute | Orthovita, Inc. | 2011 | — |
| 0 (this device) | K163621 | Vitoss Bioactive (BA) Injectable | Orthovita, Inc. | 2017 | — |
| +1 | K242797 | OsteoFlo HydroFiber | SurGenTec, LLC | 2024 | — |
| +1 | K243949 | OsteoFlo HydroFiber | SurGenTec, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2005 | 9 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K081439 | Vitoss Bioactive Foam Pack Bone Graft SubstituteSummary page 4…MQV Product Code: FMF Predicate Devices: Primary Predicate: Vitoss BA Foam Pack (K081439) Additional Predicates: Vitoss BA BiModal (K103173)… | 2008 |
| * | K103173 | Vitoss BA Bimodal Bioactive Bone Graft SubstituteSummary page 4…Vitoss BA Foam Pack (K081439) Additional Predicates: Vitoss BA BiModal (K103173) NanOss Bioactive Loaded (K141600)… | 2011 |
| * | K141600 | Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded KitSummary page 4…ditional Predicates: Vitoss BA BiModal (K103173) NanOss Bioactive Loaded (K141600) Carricell (K132868) Device Description: Vitoss BA Injectable bone graft subs… | 2014 |
| * | K132868 | CarricellSummary page 4…Vitoss BA BiModal (K103173) NanOss Bioactive Loaded (K141600) Carricell (K132868) Device Description: Vitoss BA Injectable bone graft substitute is a synthetic resorbable porous bone… | 2015 |
What descends from it? (2)
2 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 21 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 8 of the 62 ancestors have a recall of any class.
- Of its descendants, K242797 (SurGenTec, LLC, 2024) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K081439.
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. 2017, 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 BA Injectable 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 BA Injectable is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Vitoss BA Injectable is intended to be used for filling bony voids and gaps of the skeletal system (i.e. the extremities and pelvis), and may be combined with saline, autogenous blood, and/or bone marrow. 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/K163621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163621: Vitoss Bioactive (BA) Injectable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163621
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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