510(k) · Cleared
ClearedNanoBone SBX Putty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Artoss GmbH · MQV Filler, Bone Void, Calcium Compound
Cleared on Oct 26, 2016 as substantially equivalent to K141189 (Artoss GmbH, 2015) and 1 other predicate after a 163-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.
- Decided
- Oct 26, 2016
- Review
- 163 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K960978 (1996). 23 ancestors in all, the oldest K852682 (1985). 1 later device descends from it, 1 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 backK030131 Ossatura BCP Bone Void FillerIsotis NV · 2003
- 2 generations backK040082 Pore-SI Bone Graft SubstituteApatech, Ltd. · 2004
- 1 generation backK071206 Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteApatech, Ltd. · 2007 · Recalled
- This deviceK161351 NanoBone SBX PuttyArtoss GmbH · 2016
- Descendant · cites it directly · 0 of its ownK190110 NanoBone SBX PUTTY, NanoBone QDArtoss GmbH · 2019
Most influential descendants
Showing 1 of 1 · See all- K190110NanoBone SBX PUTTY, NanoBone QDArtoss GmbH · 2019 · cites it directly0descendants
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 | K030131 | Ossatura BCP Bone Void Filler | Isotis NV | 2003 | — |
| −2 | K040082 | Pore-SI Bone Graft Substitute | Apatech, Ltd. | 2004 | — |
| −1 | K071206 | Actifuse Abx E-Z-Fil Putty Bone Graft Substitute | Apatech, Ltd. | 2007 | 1 |
| 0 (this device) | K161351 | NanoBone SBX Putty | Artoss GmbH | 2016 | — |
| +1 | K190110 | NanoBone SBX PUTTY, NanoBone QD | Artoss GmbH | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K141189 | Nanobone / GranulateSummary page 4…1 CFR 888.3045, Product Code MQV Class Class II Special Controls Panel code Orthopedic / 888 Predicate Devices ARTOSS NanoBone® granulate (K141189) ApaTech Actifuse™ ABX E-Z-fil (K071206) Intended Use and NanoBone® SBX Putty is intended for use as b… | 2015 |
| * | K071206 | Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteSummary page 4…I Special Controls Panel code Orthopedic / 888 Predicate Devices ARTOSS NanoBone® granulate (K141189) ApaTech Actifuse™ ABX E-Z-fil (K071206) Intended Use and NanoBone® SBX Putty is intended for use as bone void fillers for voids or gaps that Indications… | 2007 |
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 |
|---|---|---|---|
| K190110 | NanoBone SBX PUTTY, NanoBone QD | 2019 | 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 20 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 23 ancestors have a recall of any class.
- Of its descendants, K190110 (Artoss GmbH, 2019) has gone furthest, with 0 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. 2016, 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?
NanoBone® SBX Putty is intended for use as bone void fillers for voids or gaps that are not intrinsic to the stability of the bony structure. NanoBone® SBX Putty is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. NanoBone® SBX Putty is intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., extremities and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161351: NanoBone SBX Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161351
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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