510(k) · Cleared
ClearedNB3D Bone Void Filler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Nov 22, 2011 as substantially equivalent to K091031 (Pioneer Surgical Technology, 2009) and 3 other predicates after a 137-day review. Its family tree reaches back 8 generations to 1996. 1 later device descends from it.
- Decided
- Nov 22, 2011
- Review
- 137 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K960978 (1996). 55 ancestors in all, the oldest K871773 (1987). 1 later device descends from it, 1 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 backK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
- 5 generations backK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
- 4 generations backK043308 Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005
- 3 generations backK051386 Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005
- 2 generations backK071813 Mastergraft PuttyMedtronic Sofamor Danek · 2007
- 1 generation backK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
- This deviceK111944 NB3D Bone Void FillerPioneer Surgical Technology, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK132050 NB3D Bone Void FillerPioneer Surgical Technology, Inc. · 2014 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K132050NB3D Bone Void FillerPioneer Surgical Technology, Inc. · 2014 · cites it directly0descendants
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 | K000515 | Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101… | Interpore Cross Intl. | 2000 | — |
| −5 | K012751 | Healos Bone Graft Material | Orquest, Inc. | 2001 | — |
| −4 | K043308 | Modification to: Healos Bone Graft Material | Depuy Spine, Inc. | 2005 | — |
| −3 | K051386 | Mastergraft Putty Bone Void Filler | Medtronic Vascular | 2005 | — |
| −2 | K071813 | Mastergraft Putty | Medtronic Sofamor Danek | 2007 | — |
| −1 | K082166 | Mastergraft Strip | Medtronic Sofamor Danek | 2009 | — |
| 0 (this device) | K111944 | NB3D Bone Void Filler | Pioneer Surgical Technology, Inc. | 2011 | — |
| +1 | K132050 | NB3D Bone Void Filler | Pioneer Surgical Technology, Inc. | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 9 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K091031 | Pioneer Surgical Nanoss BVF-ESummary page 2…ach of which has been determined by FDA to be substantially equivalent to pre-amendment devices: Pioneer Surgical Technology FortrOss Bone Void Filler cleared under K09 1031I; Orthovita, Inc. Vitoss'® Bioactive Foam Bone Graft Substitute-STRIP and PACK, cleared under K08 1439; Synthes (USA) ch… | 2009 |
| * | K081439 | Vitoss Bioactive Foam Pack Bone Graft SubstituteSummary page 2…Surgical Technology FortrOss Bone Void Filler cleared under K09 1031I; Orthovita, Inc. Vitoss'® Bioactive Foam Bone Graft Substitute-STRIP and PACK, cleared under K08 1439; Synthes (USA) chronOSTM Composite, cleared under K07 1046; and Medtronic Sofamor Danek MASTERORAFT® Strip, cleared under… | 2008 |
| * | K071046 | Synthes Chronos CompositeSummary page 2…09 1031I; Orthovita, Inc. Vitoss'® Bioactive Foam Bone Graft Substitute-STRIP and PACK, cleared under K08 1439; Synthes (USA) chronOSTM Composite, cleared under K07 1046; and Medtronic Sofamor Danek MASTERORAFT® Strip, cleared under K082 166. The subject device and the predicate devices are bon… | 2007 |
| * | K082166 | Mastergraft StripSummary page 2…TRIP and PACK, cleared under K08 1439; Synthes (USA) chronOSTM Composite, cleared under K07 1046; and Medtronic Sofamor Danek MASTERORAFT® Strip, cleared under K082 166. The subject device and the predicate devices are bone void fillers that are intended for bony voids or gaps that are not intrins… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132050 | NB3D Bone Void Filler | 2014 | 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 8 companies; a new generation was cleared every 2.0 years on median.
- 7 of the 55 ancestors have a recall of any class.
- Of its descendants, K132050 (Pioneer Surgical Technology, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K091031.
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?
NB3D Bone Void Filler is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created fromn traumatic injury to the bone. The product is intended to be used in conjunction with bone mnarrow aspirate and autograft bone as a bone graft extender and gently packed into bony voids or gaps in the posterolateral spine. NB3D provides an open void/gap filler that resorbs and is replaced by the growth of new bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111944 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111944: NB3D 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/K111944
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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