510(k) · Cleared
ClearedNovabone Macroform Bioactive Packable, Novabone Macroform Bioactive Composite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novabone Products, LLC · MQV Filler, Bone Void, Calcium Compound
Cleared on Aug 22, 2014 as substantially equivalent to K090731 (Novabone Products, LLC, 2009) and 1 other predicate after a 130-day review. Its family tree reaches back 7 generations to 1996. 6 later devices descend from it.
- Decided
- Aug 22, 2014
- Review
- 130 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K960978 (1996). 25 ancestors in all, the oldest K852682 (1985). 6 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 6 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 5 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 4 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 3 generations backK080009 Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008
- 2 generations backK082672 Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008
- 1 generation backK090731 Novabone Porous - Synthetic Bone Graft ScaffoldNovabone Products, LLC · 2009
- This deviceK140946 Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive…Novabone Products, LLC · 2014
- Descendant · cites it directly · 3 of its ownK180080 FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK213803 FIBERGRAFT Aeridyan Matrix Bone Graft SubstituteProsidyan, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK253147 FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty…Prosidyan, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK190371 Morpheus-CBiogennix, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK182670 FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteProsidyan, Inc. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K180080FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc. · 2018 · cites it directly3descendants
- K213803FIBERGRAFT Aeridyan Matrix Bone Graft SubstituteProsidyan, Inc. · 2022 · 2 generations on1descendant
- K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc. · 2025 · 2 generations on0descendants
- K190371Morpheus-CBiogennix, LLC · 2019 · cites it directly0descendants
- K182670FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteProsidyan, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −6 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −5 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −4 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −3 | K080009 | Novabone Putty- Bioactive Synthetic Graft | Novabone Products, LLC | 2008 | — |
| −2 | K082672 | Novabone Putty-Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2008 | — |
| −1 | K090731 | Novabone Porous - Synthetic Bone Graft Scaffold | Novabone Products, LLC | 2009 | — |
| 0 (this device) | K140946 | Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive Composite | Novabone Products, LLC | 2014 | — |
| +1 | K180080 | FIBERGRAFT BG Matrix Bone Graft Substitute | Prosidyan, Inc. | 2018 | — |
| +2 | K213803 | FIBERGRAFT Aeridyan Matrix Bone Graft Substitute | Prosidyan, Inc. | 2022 | — |
| +2 | K253147 | FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft… | Prosidyan, Inc. | 2025 | — |
| +1 | K190371 | Morpheus-C | Biogennix, LLC | 2019 | — |
| +2 | K182670 | FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute | Prosidyan, Inc. | 2018 | — |
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 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K090731 | Novabone Porous - Synthetic Bone Graft ScaffoldSummary page 4…1 CFR 888.3045 Regulation Name: Bone Void Filler Regulatory Class: Class II Product Code: MQV Legally Marketed Predicate Devices: K090731 / NovaBone Porous – Synthetic Bone Graft Scaffold K060432 K083033 Orthovita Vitoss Foam Bone Gr… | 2009 |
| * | K060432 | Novabone Porous-Bone Graft ScaffoldSummary page 4…Class II Product Code: MQV Legally Marketed Predicate Devices: K090731 / NovaBone Porous – Synthetic Bone Graft Scaffold K060432 K083033 Orthovita Vitoss Foam Bone Graft Substitute NovaBone Products, LLC NOT CONFIDENTIAL V… | 2006 |
| † | K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive… | 2008 |
What descends from it? (6)
3 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 18 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 25 ancestors has a recall of any class.
- Of its descendants, K180080 (Prosidyan, Inc., 2018) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K090731.
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. 2014, 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?
NovaBone MacroFORM bone graft devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone MacroFORM is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NovaBone MacroFORM must be hydrated with autogenous bone marrow prior to implantation. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140946 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140946: Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive Composite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140946
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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