510(k) · Cleared
ClearedNovabone Putty - Resorbable Bone Void Filler
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 Mar 6, 2006 as substantially equivalent to K021336 (Novabone Products, LLC, 2002) and 1 other predicate after a 262-day review. Its family tree reaches back 4 generations to 1996. 5 later devices descend from it.
- Decided
- Mar 6, 2006
- Review
- 262 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K960978 (1996). 14 ancestors in all, the oldest K852682 (1985). 5 later devices descend from it, 2 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 backK041613 Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004
- This deviceK051617 Novabone Putty - Resorbable Bone Void FillerNovabone Products, LLC · 2006
- Descendant · cites it directly · 4 of its ownK063596 Perioglas Putty-Bioactive Bone Graft GelNovabone Products, LLC · 2007
- Descendant · cites it directly · 3 of its ownK081432 Healos II Bone Graft SubstituteDepuy Spine, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK101827 OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011
- Descendant · 3 generations on · 0 of its ownK213260 CMFlexTMDimension Inx Corp. · 2022
- Descendant · 2 generations on · 0 of its ownK093390 Healos Dental Bone Graft Substitute (Also Called Healos or Healos…Depuy Spine, Inc. · 2010
Most influential descendants
Showing 5 of 5 · See all- K063596Perioglas Putty-Bioactive Bone Graft GelNovabone Products, LLC · 2007 · cites it directly4descendants
- K081432Healos II Bone Graft SubstituteDepuy Spine, Inc. · 2008 · cites it directly3descendants
- K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011 · 2 generations on1descendant
- K213260CMFlexTMDimension Inx Corp. · 2022 · 3 generations on0descendants
- K093390Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025Depuy Spine, Inc. · 2010 · 2 generations on0descendants
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 | K041613 | Novabone - AR - Resorbable Bone Graft Substitute | Novabone Products, LLC | 2004 | — |
| 0 (this device) | K051617 | Novabone Putty - Resorbable Bone Void Filler | Novabone Products, LLC | 2006 | — |
| +1 | K063596 | Perioglas Putty-Bioactive Bone Graft Gel | Novabone Products, LLC | 2007 | — |
| +1 | K081432 | Healos II Bone Graft Substitute | Depuy Spine, Inc. | 2008 | — |
| +2 | K101827 | Osteoscaf | Texas Innovative Medical Devices (Dba) Skeletal | 2011 | — |
| +3 | K213260 | CMFlexTM | Dimension Inx Corp. | 2022 | — |
| +2 | K093390 | Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model… | Depuy Spine, Inc. | 2010 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K021336 | Novabone-Resorbable Bone Graft SubstituteSummary page 1…cation Name: Unknown 3. Legally Marketed Predicate Device: Predicate # 1: NovaBone -- Resorbable Bone Graft Substitute [K02 1336] Predicate #2: NovaBone-AR - Resorbable Bone Graft Substitute [KO4 16 13] 4. D… | 2002 |
| * | K041613 | Novabone - AR - Resorbable Bone Graft Substitute | 2004 |
What descends from it? (5)
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 10 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K063596 (Novabone Products, LLC, 2007) has gone furthest, with 4 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 Putty - Resorbable Bone Void Filler 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051617: Novabone Putty - Resorbable Bone Void Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051617
Report an extraction error
Are you the manufacturer?
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