510(k) · Cleared
ClearedNovabne Putty Bioactive Synthetic Bone 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 Oct 14, 2011 as substantially equivalent to K060728 (Novabone Products, LLC, 2006) and 4 other predicates after a 21-day review. Its family tree reaches back 8 generations to 1996. 38 later devices descend from it.
- Decided
- Oct 14, 2011
- Review
- 21 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K960978 (1996). 24 ancestors in all, the oldest K852682 (1985). 38 later devices descend from it, 7 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 backK080009 Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008
- 3 generations backK082672 Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008
- 2 generations backK101860 Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010
- 1 generation backK110368 Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- This deviceK112773 Novabne Putty Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- Descendant · cites it directly · 33 of its ownK132805 BG MorselsProsidyan, Inc. · 2014
- Descendant · cites it directly · 31 of its ownK151154 FIBERGRAFT BG MorselsProsidyan, Inc. · 2015
- Descendant · cites it directly · 31 of its ownK143533 Fibergraft BG Putty Bone Graft SubstituteProsidyan, Inc. · 2015
- Descendant · cites it directly · 30 of its ownK170306 FIBERGRAFT BG Putty Bone Graft SubstituteProsidyan, Inc. · 2017
- Descendant · 2 generations on · 29 of its ownK222276 CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K132805BG MorselsProsidyan, Inc. · 2014 · cites it directly33descendants
- K151154FIBERGRAFT BG MorselsProsidyan, Inc. · 2015 · cites it directly31descendants
- K143533Fibergraft BG Putty Bone Graft SubstituteProsidyan, Inc. · 2015 · cites it directly31descendants
- K170306FIBERGRAFT BG Putty Bone Graft SubstituteProsidyan, Inc. · 2017 · cites it directly30descendants
- K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022 · 2 generations on29descendants
View 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 | K080009 | Novabone Putty- Bioactive Synthetic Graft | Novabone Products, LLC | 2008 | — |
| −3 | K082672 | Novabone Putty-Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2008 | — |
| −2 | K101860 | Novabone Putty- Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2010 | — |
| −1 | K110368 | Novabone Putty - Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2011 | — |
| 0 (this device) | K112773 | Novabne Putty Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2011 | — |
| +1 | K132805 | BG Morsels | Prosidyan, Inc. | 2014 | — |
| +1 | K151154 | FIBERGRAFT BG Morsels | Prosidyan, Inc. | 2015 | — |
| +1 | K143533 | Fibergraft BG Putty Bone Graft Substitute | Prosidyan, Inc. | 2015 | — |
| +1 | K170306 | FIBERGRAFT BG Putty Bone Graft Substitute | Prosidyan, Inc. | 2017 | — |
| +2 | K222276 | CONDUIT Cages; FIBERGRAFT BG Putty | Depuy Spine | 2022 | — |
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 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 8 | 0 |
| 2025 | 13 | 0 |
| 2026 | 5 | 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? (5)
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…Void Filler 3. Legally Marketed Predicate Device: Predicate #I: NovaBone Putty - Bioactive Synthetic Graft [K060728, K080009, K082672, K 10 1860, K 1103 68] 4. Device Description NovaBone Putty is an osteoconductive, bioactive. bon… | 2006 |
| * | K080009 | Novabone Putty- Bioactive Synthetic GraftSummary page 1…ler 3. Legally Marketed Predicate Device: Predicate #I: NovaBone Putty - Bioactive Synthetic Graft [K060728, K080009, K082672, K 10 1860, K 1103 68] 4. Device Description NovaBone Putty is an osteoconductive, bioactive. bone void fi… | 2008 |
| * | K082672 | Novabone Putty-Bioactive Synthetic Bone GraftSummary page 1…Legally Marketed Predicate Device: Predicate #I: NovaBone Putty - Bioactive Synthetic Graft [K060728, K080009, K082672, K 10 1860, K 1103 68] 4. Device Description NovaBone Putty is an osteoconductive, bioactive. bone void filler devi… | 2008 |
| * | K101860 | Novabone Putty- Bioactive Synthetic Bone GraftSummary page 1…y Marketed Predicate Device: Predicate #I: NovaBone Putty - Bioactive Synthetic Graft [K060728, K080009, K082672, K 10 1860, K 1103 68] 4. Device Description NovaBone Putty is an osteoconductive, bioactive. bone void filler device. It is… | 2010 |
| * | K110368 | Novabone Putty - Bioactive Synthetic Bone GraftSummary page 1…Predicate Device: Predicate #I: NovaBone Putty - Bioactive Synthetic Graft [K060728, K080009, K082672, K 10 1860, K 1103 68] 4. Device Description NovaBone Putty is an osteoconductive, bioactive. bone void filler device. It is comp… | 2011 |
What descends from it? (38)
See all 387 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132805 | BG Morsels | 2014 | 33 |
| K151154 | FIBERGRAFT BG Morsels | 2015 | 31 |
| K143533 | Fibergraft BG Putty Bone Graft Substitute | 2015 | 31 |
| K170306 | FIBERGRAFT BG Putty Bone Graft Substitute | 2017 | 30 |
| K240404 | NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) | 2024 | 1 |
| K163310 | NovaBone IRM | 2017 | 0 |
| K160978 | LITe BIO Delivery System | 2016 | 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 15 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 24 ancestors has a recall of any class.
- Of its descendants, K132805 (Prosidyan, Inc., 2014) has gone furthest, with 33 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. 2011, 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 Bone 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, posterolateral 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…
Read the full statement (110 words)
NovaBone Putty - Bioactive Synthetic Bone 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, posterolateral 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; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K112773 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112773: Novabne Putty Bioactive Synthetic Bone Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112773
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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