510(k) · Cleared
Cleared0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amend Surgical, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Feb 16, 2017 as substantially equivalent to K142104 (Nanotherapeutics, Inc., 2015) after a 212-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Feb 16, 2017
- Review
- 212 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K960978 (1996). 9 ancestors in all. No later device cites it as a predicate yet.
- 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 backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 4 generations backK062459 Origen DBM with Bioactive GlassNanotherapeutics · 2007
- 3 generations backK110976 Origen DBM with Bioactive Glass, Nanofuse DBMNanotherapeutics, Inc. · 2011 · Recalled
- 2 generations backK120279 Nanofuse DBMNanotherapeutics · 2012
- 1 generation backK142104 Nanofuse DBMNanotherapeutics, Inc. · 2015
- This deviceK161996 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc…Amend Surgical, Inc. · 2017
View 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 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −4 | K062459 | Origen DBM with Bioactive Glass | Nanotherapeutics | 2007 | — |
| −3 | K110976 | Origen DBM with Bioactive Glass, Nanofuse DBM | Nanotherapeutics, Inc. | 2011 | 2 |
| −2 | K120279 | Nanofuse DBM | Nanotherapeutics | 2012 | — |
| −1 | K142104 | Nanofuse DBM | Nanotherapeutics, Inc. | 2015 | — |
| 0 (this device) | K161996 | 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE | Amend Surgical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2005 | 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? (1)
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.
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 9 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. 2017, 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?
NanoFUSE® is indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e. the posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NanoFUSE® must be used with autograft as a bone graft extender in the posterolateral spine and pelvis. The product provides a bone graft substitute that remodels into the recipient's skeletal system.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161996 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161996: 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161996
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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