510(k) · Cleared
Recalled · Class II · 2026NB3D 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 Feb 7, 2014 as substantially equivalent to K111944 (Pioneer Surgical Technology, Inc., 2011) and 1 other predicate after a 220-day review. Its family tree reaches back 9 generations to 1996. It has been recalled once.
- Decided
- Feb 7, 2014
- Review
- 220 days
- Class
- Class II
- Product code
- MQV
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 9 generations to K960978 (1996). 60 ancestors in all, the oldest K871773 (1987). No later device cites it as a predicate yet.
- Root · 9 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 5 generations between
- 3 generations backK071813 Mastergraft PuttyMedtronic Sofamor Danek · 2007
- 2 generations backK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
- 1 generation backK111944 NB3D Bone Void FillerPioneer Surgical Technology, Inc. · 2011
- This deviceK132050 NB3D Bone Void FillerPioneer Surgical Technology, Inc. · 2014
Show all 9 generations
- Root · 9 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 8 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 7 generations backK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
- 6 generations backK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
- 5 generations backK043308 Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005
- 4 generations backK051386 Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005
- 3 generations backK071813 Mastergraft PuttyMedtronic Sofamor Danek · 2007
- 2 generations backK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
- 1 generation backK111944 NB3D Bone Void FillerPioneer Surgical Technology, Inc. · 2011
- This deviceK132050 NB3D Bone Void FillerPioneer Surgical Technology, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −8 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −7 | K000515 | Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101… | Interpore Cross Intl. | 2000 | — |
| −6 | K012751 | Healos Bone Graft Material | Orquest, Inc. | 2001 | — |
| −5 | K043308 | Modification to: Healos Bone Graft Material | Depuy Spine, Inc. | 2005 | — |
| −4 | K051386 | Mastergraft Putty Bone Void Filler | Medtronic Vascular | 2005 | — |
| −3 | K071813 | Mastergraft Putty | Medtronic Sofamor Danek | 2007 | — |
| −2 | K082166 | Mastergraft Strip | Medtronic Sofamor Danek | 2009 | — |
| −1 | K111944 | NB3D Bone Void Filler | Pioneer Surgical Technology, Inc. | 2011 | — |
| 0 (this device) | K132050 | NB3D Bone Void Filler | Pioneer Surgical Technology, Inc. | 2014 | — |
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 | 7 | 0 |
| 2004 | 3 | 0 |
| 2005 | 9 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K111944 | NB3D Bone Void FillerSummary page 3…Same as KI111944 and K(083033 Basic Design Same as KI 11944 Form Same as K111944 Performance Performed SE to K(083033 Manufacturing Principl… | 2011 |
| * | K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive…Summary page 1…nel; Panel Code 87 Restorative Devices Branch Predicates: Ki 11944 NB3D Bone Void Filler (SE 11 -22-2011) K083033 Vitoss Bone Graft Substitute, Vitoss Bone Graft Substitute filled Canister, Vitoss Foam Bone Graft Subst… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 9, 2026 | Class II | Z-1897-2026 | Incorrect or no expiration date | Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 8 companies; a new generation was cleared every 2.0 years on median.
- 7 of the 60 ancestors have a recall of any class.
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. 2014, 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 is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structures. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NB3D is indicated to be gently packed into bony voids or gaps of the skeletal system (extremities and pelvis) un-hydrated or in conjunction with bone marrow aspirate or autogenous blood, or in the posterolateral spine in conjunction with bone marrow aspirate and autograft bone as a bone graft extender. 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/K132050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132050: 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/K132050
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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