510(k) · Cleared
ClearedNovabone - AR - Resorbable Bone Graft Substitute
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 25, 2004 as substantially equivalent to K021336 (Novabone Products, LLC, 2002) and 1 other predicate after a 71-day review. Its family tree reaches back 3 generations to 1996. 84 later devices descend from it.
- Decided
- Aug 25, 2004
- Review
- 71 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K960978 (1996). 13 ancestors in all, the oldest K852682 (1985). 84 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 2 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 1 generation backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- This deviceK041613 Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004
- Descendant · cites it directly · 59 of its ownK082672 Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008
- Descendant · 2 generations on · 47 of its ownK101860 Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010
- Descendant · 2 generations on · 43 of its ownK110368 Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- Descendant · 2 generations on · 38 of its ownK112773 Novabne Putty Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- Descendant · 3 generations on · 33 of its ownK132805 BG MorselsProsidyan, Inc. · 2014
Showing 5 of 84 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 84 · See all- K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008 · cites it directly59descendants
- K101860Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010 · 2 generations on47descendants
- K110368Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011 · 2 generations on43descendants
- K112773Novabne Putty Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011 · 2 generations on38descendants
- K132805BG MorselsProsidyan, Inc. · 2014 · 3 generations on33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −2 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −1 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| 0 (this device) | K041613 | Novabone - AR - Resorbable Bone Graft Substitute | Novabone Products, LLC | 2004 | — |
| +1 | K082672 | Novabone Putty-Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2008 | — |
| +2 | K101860 | Novabone Putty- Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2010 | — |
| +2 | K110368 | Novabone Putty - Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2011 | — |
| +2 | K112773 | Novabne Putty Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2011 | — |
| +3 | K132805 | BG Morsels | Prosidyan, Inc. | 2014 | — |
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 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 9 | 0 |
| 2024 | 9 | 0 |
| 2025 | 13 | 0 |
| 2026 | 7 | 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 |
|---|---|---|---|
| * | K021336 | Novabone-Resorbable Bone Graft SubstituteSummary page 1…Legally Marketed Predicate Device: Predicate # 1: NovaBone - Resorbable Bone Graft Substitute [K02 1336] Predicate #2: NovaBone-BBG - Resorbable Bone Graft Substitute… | 2002 |
| * | K033994 | Novabone-BBG-Resorbable Bone Graft SubstituteSummary page 1…[K02 1336] Predicate #2: NovaBone-BBG - Resorbable Bone Graft Substitute [K033994] 4. Device Description Noval~one-AR is a synthetic resorbable osteoconductive bone graft substitute… | 2004 |
What descends from it? (84)
See all 845 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 8 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K082672 (Novabone Products, LLC, 2008) has gone furthest, with 59 descendants of its own.
- 12 other devices also cite its predicate K021336.
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.
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-AR Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone-AR 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 tihe healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041613 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041613: Novabone - AR - Resorbable 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/K041613
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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