510(k) · Cleared
ClearedNovabone Putty- Bioactive Synthetic Graft
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 May 6, 2008 as substantially equivalent to K060728 (Novabone Products, LLC, 2006) and 2 other predicates after a 124-day review. Its family tree reaches back 4 generations to 1996. 71 later devices descend from it.
- Decided
- May 6, 2008
- Review
- 124 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K960978 (1996). 10 ancestors in all. 71 later devices descend from it, 13 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 deviceK080009 Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008
- Descendant · cites it directly · 59 of its ownK082672 Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008
- Descendant · cites it directly · 47 of its ownK101860 Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010
- Descendant · cites it directly · 43 of its ownK110368 Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- Descendant · cites it directly · 38 of its ownK112773 Novabne Putty Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- Descendant · 2 generations on · 33 of its ownK132805 BG MorselsProsidyan, Inc. · 2014
Showing 5 of 71 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 71 · See all- K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008 · cites it directly59descendants
- K101860Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010 · cites it directly47descendants
- K110368Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011 · cites it directly43descendants
- K112773Novabne Putty Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011 · cites it directly38descendants
- K132805BG MorselsProsidyan, Inc. · 2014 · 2 generations on33descendants
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) | K080009 | Novabone Putty- Bioactive Synthetic Graft | Novabone Products, LLC | 2008 | — |
| +1 | K082672 | Novabone Putty-Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2008 | — |
| +1 | K101860 | Novabone Putty- Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2010 | — |
| +1 | K110368 | Novabone Putty - Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2011 | — |
| +1 | K112773 | Novabne Putty Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2011 | — |
| +2 | K132805 | BG Morsels | Prosidyan, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 9 | 0 |
| 2024 | 8 | 0 |
| 2025 | 13 | 0 |
| 2026 | 6 | 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? (3)
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 |
|---|---|---|---|
| * | K060728 | Novabone Putty - Bioactive Synthetic GraftSummary page 1…Bone Void Filler 3. Legally Marketed Predicate Device: Predicate #1: NovaBone Putty - Bioactive Synthetic Graft - [K060728] Predicate #2: NovaBone - Resorbable Bone Graft Substitute - [K021336, K052494]… | 2006 |
| * | K021336 | Novabone-Resorbable Bone Graft SubstituteSummary page 1…ynthetic Graft - [K060728] Predicate #2: NovaBone - Resorbable Bone Graft Substitute - [K021336, K052494] 4. Device Description NovaBone Putty is an osteoconductive, bioactive, bone void filler device. It is compo… | 2002 |
| * | K052494 | Novabone-Bioactive Synthetic GraftSummary page 1…Graft - [K060728] Predicate #2: NovaBone - Resorbable Bone Graft Substitute - [K021336, K052494] 4. Device Description NovaBone Putty is an osteoconductive, bioactive, bone void filler device. It is composed of a… | 2005 |
What descends from it? (71)
See all 7113 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082672 | Novabone Putty-Bioactive Synthetic Bone Graft | 2008 | 59 |
| K101860 | Novabone Putty- Bioactive Synthetic Bone Graft | 2010 | 47 |
| K110368 | Novabone Putty - Bioactive Synthetic Bone Graft | 2011 | 43 |
| K112773 | Novabne Putty Bioactive Synthetic Bone Graft | 2011 | 38 |
| K143533 | Fibergraft BG Putty Bone Graft Substitute | 2015 | 31 |
| K170306 | FIBERGRAFT BG Putty Bone Graft Substitute | 2017 | 30 |
| K090731 | Novabone Porous - Synthetic Bone Graft Scaffold | 2009 | 10 |
| K130392 | Kinex Bioactive | 2013 | 8 |
| K240404 | NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) | 2024 | 1 |
| K140844 | Biosphere Bioactive Bone Graft Putty, 2.5CC, 5CC, 10CC | 2014 | 1 |
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 3 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K082672 (Novabone Products, LLC, 2008) has gone furthest, with 59 descendants of its own.
- 13 other devices also cite its predicate K060728.
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?
NovaBone Putty - Bioactive Synthetic Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and…
Read the full statement (162 words)
NovaBone Putty - Bioactive Synthetic Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
NovaBone Putty is not indicated for use in load-bearing applications. It does not possess sufficient mechanical strength to support load-bearing defects prior to hard tissue ingrowth. It should not be used for vertebroplasty or kyphoplasty procedures. In cases of fracture fixation or where load support is required, standard internal or external stabilization techniques must be followed to obtain rigid stabilization in all planes. NovaBone Putty must not be used to gain screw purchase or to stabilize screw placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080009: Novabone Putty- Bioactive Synthetic Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080009
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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