510(k) · Cleared
ClearedKensey Nash Bone Void Filler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kensey Nash Corporation · MQV Filler, Bone Void, Calcium Compound
Cleared on Sep 22, 2006 as substantially equivalent to K040047 (Osteobiologics, Inc., 2004) and 3 other predicates after a 171-day review. Its family tree reaches back 6 generations to 1996. 7 later devices descend from it.
- Decided
- Sep 22, 2006
- Review
- 171 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K960978 (1996). 19 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 5 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 4 generations backK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
- 3 generations backK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
- 2 generations backK043308 Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005
- 1 generation backK051386 Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005
- This deviceK060917 Kensey Nash Bone Void FillerKensey Nash Corporation · 2006
- Descendant · cites it directly · 4 of its ownK071187 Microfuse Bone Void FillerGlobus Medical, Inc. · 2007
- Descendant · 2 generations on · 2 of its ownK082442 Modification to Microfuse Bone Void FillerGlobus Medical, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK083232 Modification to:Microfuse Bone Void FillerGlobus Medical, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK120141 Kensey Nash Bone Void Filler XCKensey Nash Cororation · 2012
- Descendant · 2 generations on · 0 of its ownK102392 Microfuse Putty and Microfuse ST MisGlobus Medical, Inc. · 2010 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K071187Microfuse Bone Void FillerGlobus Medical, Inc. · 2007 · cites it directly4descendants
- K082442Modification to Microfuse Bone Void FillerGlobus Medical, Inc. · 2008 · 2 generations on2descendants
- K083232Modification to:Microfuse Bone Void FillerGlobus Medical, Inc. · 2008 · 2 generations on1descendant
- K120141Kensey Nash Bone Void Filler XCKensey Nash Cororation · 2012 · cites it directly0descendants
- K102392Microfuse Putty and Microfuse ST MisGlobus Medical, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −5 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −4 | K000515 | Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101… | Interpore Cross Intl. | 2000 | — |
| −3 | K012751 | Healos Bone Graft Material | Orquest, Inc. | 2001 | — |
| −2 | K043308 | Modification to: Healos Bone Graft Material | Depuy Spine, Inc. | 2005 | — |
| −1 | K051386 | Mastergraft Putty Bone Void Filler | Medtronic Vascular | 2005 | — |
| 0 (this device) | K060917 | Kensey Nash Bone Void Filler | Kensey Nash Corporation | 2006 | — |
| +1 | K071187 | Microfuse Bone Void Filler | Globus Medical, Inc. | 2007 | — |
| +2 | K082442 | Modification to Microfuse Bone Void Filler | Globus Medical, Inc. | 2008 | — |
| +2 | K083232 | Modification to:Microfuse Bone Void Filler | Globus Medical, Inc. | 2008 | — |
| +1 | K120141 | Kensey Nash Bone Void Filler XC | Kensey Nash Cororation | 2012 | — |
| +2 | K102392 | Microfuse Putty and Microfuse ST Mis | Globus Medical, Inc. | 2010 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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? (4)
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 |
|---|---|---|---|
| * | K040047 | Polygraft BGS; Bone Graft SubstituteSummary page 1…DEVICE 510k.# OsteoBiologics PolyGraft"M BGS K040047 OsteoBiologics PolyGraflTM TCP K033707 Kenscy Nash [Centerpulse Spine… | 2004 |
| * | K033707 | Polygraft TCP Granules, Cubes, Blocks, Plugs, Wedges, Models 600-023-XX, 600-025-XX…Summary page 1…PolyGraft"M BGS K040047 OsteoBiologics PolyGraflTM TCP K033707 Kenscy Nash [Centerpulse Spine-Tech] CopiOsTM Bone Void Filler K033679 Medtronic… | 2004 |
| * | K033679 | Copsios Bone Void Filler (BVF)Summary page 1…PolyGraflTM TCP K033707 Kenscy Nash [Centerpulse Spine-Tech] CopiOsTM Bone Void Filler K033679 Medtronic MasterGraft® Putty K051386 Substantial Equivalence: Kense… | 2004 |
| * | K051386 | Mastergraft Putty Bone Void FillerSummary page 1…ulse Spine-Tech] CopiOsTM Bone Void Filler K033679 Medtronic MasterGraft® Putty K051386 Substantial Equivalence: Kensey Nash BVF is substantially equivalent to the legally marketed predicate devices with regard to int… | 2005 |
What descends from it? (7)
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 10 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K071187 (Globus Medical, Inc., 2007) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K040047.
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?
The Kensey Nash Bone Void Filler is intended to be gently packed into the bony voids or gaps of the extremities and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. These defects may be created from traumatic injury to the bone or surgically created osseous defects for the harvest of bone. The device provides a bone void filler that resorbs and is replaced with bone during the healing process. The device may be combined with sterile fluids such as saline or autogenous blood products such as blood or bone marrow aspirate. The addition of these autogenous products does not alter the performance of the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060917 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060917: Kensey Nash Bone Void Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060917
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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