510(k) · Cleared
ClearedPioneer Surgical Nanoss BVF-E
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology · MQV Filler, Bone Void, Calcium Compound
Cleared on Nov 17, 2009 as substantially equivalent to K081558 (Pioneer Surgical Technology, 2008) and 3 other predicates after a 221-day review. Its family tree reaches back 5 generations to 1996. 7 later devices descend from it.
- Decided
- Nov 17, 2009
- Review
- 221 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K960978 (1996). 24 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 4 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 3 generations backK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
- 2 generations backK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
- 1 generation backK050789 Formagraft Collagen Bone Graft MatrixR and D Medical, LLC · 2005
- This deviceK091031 Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology · 2009
- Descendant · cites it directly · 4 of its ownK110561 Fortross Bone Void FillerPioneer Surgical Technology · 2011
- Descendant · 2 generations on · 3 of its ownK141600 Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive…Pioneer Surgical Technology, Inc. (Rti Surgical, I · 2014
- Descendant · 3 generations on · 2 of its ownK163621 Vitoss Bioactive (BA) InjectableOrthovita, Inc. · 2017
- Descendant · 4 generations on · 1 of its ownK242797 OsteoFlo HydroFiberSurGenTec, LLC · 2024
- Descendant · cites it directly · 1 of its ownK111944 NB3D Bone Void FillerPioneer Surgical Technology, Inc. · 2011
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K110561Fortross Bone Void FillerPioneer Surgical Technology · 2011 · cites it directly4descendants
- K141600Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded KitPioneer Surgical Technology, Inc. (Rti Surgical, I · 2014 · 2 generations on3descendants
- K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc. · 2017 · 3 generations on2descendants
- K242797OsteoFlo HydroFiberSurGenTec, LLC · 2024 · 4 generations on1descendant
- K111944NB3D Bone Void FillerPioneer Surgical Technology, Inc. · 2011 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −4 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −3 | K000515 | Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101… | Interpore Cross Intl. | 2000 | — |
| −2 | K012751 | Healos Bone Graft Material | Orquest, Inc. | 2001 | — |
| −1 | K050789 | Formagraft Collagen Bone Graft Matrix | R and D Medical, LLC | 2005 | — |
| 0 (this device) | K091031 | Pioneer Surgical Nanoss BVF-E | Pioneer Surgical Technology | 2009 | — |
| +1 | K110561 | Fortross Bone Void Filler | Pioneer Surgical Technology | 2011 | — |
| +2 | K141600 | Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded Kit | Pioneer Surgical Technology, Inc. (Rti Surgical, I | 2014 | — |
| +3 | K163621 | Vitoss Bioactive (BA) Injectable | Orthovita, Inc. | 2017 | — |
| +4 | K242797 | OsteoFlo HydroFiber | SurGenTec, LLC | 2024 | — |
| +1 | K111944 | NB3D Bone Void Filler | Pioneer Surgical Technology, Inc. | 2011 | — |
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 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K081558 | Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CCSummary page 2…may include ceramic materials, porcine gelatin carrier, porous structure, and presentation are cited below. Devices to Which Substantial Equivalence is Claimed: K081558 - Pioneer Surgical NanOss BVF-E K082575 - Actifuse' Tm Bone Graft Substitute K050798 - Formalraft'M Collagen Bone G… | 2008 |
| * | K082575 | Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft SubstitutesSummary page 2…carrier, porous structure, and presentation are cited below. Devices to Which Substantial Equivalence is Claimed: K081558 - Pioneer Surgical NanOss BVF-E K082575 - Actifuse' Tm Bone Graft Substitute K050798 - Formalraft'M Collagen Bone Graft Matrix K032288 - Vitoss Scaffold Fo… | 2008 |
| * | K050789 | Formagraft Collagen Bone Graft Matrix Our reading of the summary gave K050798, FDA’s number for Eclipse Neurological Workstation (Axon Systems, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Formalraft'M Collagen Bone Graft Matrix”. | 2005 |
| * | K032288 | Vitoss Scaffold Foam Bone Graft MaterialSummary page 2…aimed: K081558 - Pioneer Surgical NanOss BVF-E K082575 - Actifuse' Tm Bone Graft Substitute K050798 - Formalraft'M Collagen Bone Graft Matrix K032288 - Vitoss Scaffold Foam The comparisons and testing conducted on FortrOss Bone Void Filler demonstrate that the device is substan… | 2003 |
What descends from it? (7)
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 13 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 24 ancestors have a recall of any class.
- Of its descendants, K110561 (Pioneer Surgical Technology, 2011) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K081558.
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. 2009, 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?
Pioneer ForirOssBone Void Filler is indicated 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 from traumatic injury to the bone. The product is indicated to be used in the posterolateral spine in conjunction with bone marrow aspirate and autograft 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/K091031 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091031: Pioneer Surgical Nanoss BVF-E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091031
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