510(k) · Cleared
ClearedNanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology, Inc. (Rti Surgical, I · MQV Filler, Bone Void, Calcium Compound
Cleared on Oct 17, 2014 as substantially equivalent to K110561 (Pioneer Surgical Technology, 2011) and 1 other predicate after a 123-day review. Its family tree reaches back 7 generations to 1996. 3 later devices descend from it.
- Decided
- Oct 17, 2014
- Review
- 123 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K960978 (1996). 27 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 6 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 5 generations backK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
- 4 generations backK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
- 3 generations backK050789 Formagraft Collagen Bone Graft MatrixR and D Medical, LLC · 2005
- 2 generations backK091031 Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology · 2009
- 1 generation backK110561 Fortross Bone Void FillerPioneer Surgical Technology · 2011
- This deviceK141600 Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive…Pioneer Surgical Technology, Inc. (Rti Surgical, I · 2014
- Descendant · cites it directly · 2 of its ownK163621 Vitoss Bioactive (BA) InjectableOrthovita, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK242797 OsteoFlo HydroFiberSurGenTec, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK243949 OsteoFlo HydroFiberSurGenTec, LLC · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −6 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −5 | K000515 | Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101… | Interpore Cross Intl. | 2000 | — |
| −4 | K012751 | Healos Bone Graft Material | Orquest, Inc. | 2001 | — |
| −3 | K050789 | Formagraft Collagen Bone Graft Matrix | R and D Medical, LLC | 2005 | — |
| −2 | K091031 | Pioneer Surgical Nanoss BVF-E | Pioneer Surgical Technology | 2009 | — |
| −1 | K110561 | Fortross Bone Void Filler | Pioneer Surgical Technology | 2011 | — |
| 0 (this device) | K141600 | Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded Kit | Pioneer Surgical Technology, Inc. (Rti Surgical, I | 2014 | — |
| +1 | K163621 | Vitoss Bioactive (BA) Injectable | Orthovita, Inc. | 2017 | — |
| +2 | K242797 | OsteoFlo HydroFiber | SurGenTec, LLC | 2024 | — |
| +2 | K243949 | OsteoFlo HydroFiber | SurGenTec, LLC | 2025 | — |
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 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K110561 | Fortross Bone Void FillerSummary page 4…t Code MQV) Regulations: 21 CFR 888.3045, Class II Classification Panel: Orthopaedic and Rehabilitation Devices Predicate: FortrOss Bone Void Filler (K110561) NanOss™ BVF-E (K100361) Intended Use: NanOss™ is intended for bony voids or gaps that are not intri… | 2011 |
| * | K100361 | Nanoss Bone Void FillerSummary page 4…045, Class II Classification Panel: Orthopaedic and Rehabilitation Devices Predicate: FortrOss Bone Void Filler (K110561) NanOss™ BVF-E (K100361) Intended Use: NanOss™ is intended for bony voids or gaps that are not intrinsic to the stability of… | 2010 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163621 | Vitoss Bioactive (BA) Injectable | 2017 | 2 |
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 18 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 27 ancestors have a recall of any class.
- Of its descendants, K163621 (Orthovita, Inc., 2017) has gone furthest, with 2 descendants of its own.
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?
NanOss™ is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (i.e., extremities, posterolateral spine, and pelvis). NanOss must be mixed with autogenous blood or sterile saline for use in the extremities or pelvis. NanOss must be mixed with bone marrow aspirate and autograft bone as a bone graft extender in the posterolateral spine. These defects may be surgically created osseous defects or 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/K141600 · printed Nov 4, 2026
Cite this page
510(k) Report. “K141600: Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K141600
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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