510(k) · Cleared
ClearedMagnetOs Putty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kuros Biosciences B.V · MQV Filler, Bone Void, Calcium Compound
Cleared on Aug 24, 2017 as substantially equivalent to K161859 (Xpand Biotechnology BV, 2017) and 3 other predicates after an 86-day review. Its family tree reaches back 7 generations to 1996. 4 later devices descend from it.
- Decided
- Aug 24, 2017
- Review
- 86 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K960978 (1996). 26 ancestors in all. 4 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 backK030131 Ossatura BCP Bone Void FillerIsotis NV · 2003
- 4 generations backK040082 Pore-SI Bone Graft SubstituteApatech, Ltd. · 2004
- 3 generations backK071206 Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteApatech, Ltd. · 2007 · Recalled
- 2 generations backK080736 Actifuse Shape Bone Graft SubstituteApatech, Ltd. · 2008
- 1 generation backK151584 AttraX PuttyProgentix Orthobiology BV · 2015
- This deviceK171563 MagnetOs PuttyKuros Biosciences B.V · 2017
- Descendant · cites it directly · 3 of its ownK211201 MagnetOs Easypack PuttyKuros Biosciences B.V · 2021
- Descendant · 2 generations on · 2 of its ownK233607 MagnetOs Easypack PuttyKuros Biosciences B.V · 2023
- Descendant · 3 generations on · 1 of its ownK241212 MagnetOs Easypack PuttyKuros Biosciences · 2024
- Descendant · 4 generations on · 0 of its ownK243474 MagnetOs MISKuros Biosciences B.V · 2025
Most influential descendants
Showing 4 of 4 · See all- K211201MagnetOs Easypack PuttyKuros Biosciences B.V · 2021 · cites it directly3descendants
- K233607MagnetOs Easypack PuttyKuros Biosciences B.V · 2023 · 2 generations on2descendants
- K241212MagnetOs Easypack PuttyKuros Biosciences · 2024 · 3 generations on1descendant
- K243474MagnetOs MISKuros Biosciences B.V · 2025 · 4 generations on0descendants
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 | K030131 | Ossatura BCP Bone Void Filler | Isotis NV | 2003 | — |
| −4 | K040082 | Pore-SI Bone Graft Substitute | Apatech, Ltd. | 2004 | — |
| −3 | K071206 | Actifuse Abx E-Z-Fil Putty Bone Graft Substitute | Apatech, Ltd. | 2007 | 1 |
| −2 | K080736 | Actifuse Shape Bone Graft Substitute | Apatech, Ltd. | 2008 | — |
| −1 | K151584 | AttraX Putty | Progentix Orthobiology BV | 2015 | — |
| 0 (this device) | K171563 | MagnetOs Putty | Kuros Biosciences B.V | 2017 | — |
| +1 | K211201 | MagnetOs Easypack Putty | Kuros Biosciences B.V | 2021 | — |
| +2 | K233607 | MagnetOs Easypack Putty | Kuros Biosciences B.V | 2023 | — |
| +3 | K241212 | MagnetOs Easypack Putty | Kuros Biosciences | 2024 | — |
| +4 | K243474 | MagnetOs MIS | Kuros Biosciences B.V | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K161859 | MagnetOsSummary page 5…lly equivalent in indications and design principles to the following legally marketed predicate devices: Xpand Biotechnology B.V., MagnetOs (granules), cleared under K161859; Note: Xpand Biotechnology B.V. is the previous company name of Kuros Biosciences B.V. Progentix Orthobiology B.V., Attra… | 2017 |
| * | K151584 | AttraX PuttySummary page 5…red under K161859; Note: Xpand Biotechnology B.V. is the previous company name of Kuros Biosciences B.V. Progentix Orthobiology B.V., AttraX Putty, cleared under K151584; Biostructures LLC, Signafuse Bioactive Bone Graft Putty; cleared under K132071; Synthes; chronOS Composite; cleared unde… | 2015 |
| * | K132071 | Bioactive Bone Graft PuttySummary page 5…f Kuros Biosciences B.V. Progentix Orthobiology B.V., AttraX Putty, cleared under K151584; Biostructures LLC, Signafuse Bioactive Bone Graft Putty; cleared under K132071; Synthes; chronOS Composite; cleared under K071046. The subject device and predicate devices K161859, K151584, K132071, and K… | 2014 |
| * | K071046 | Synthes Chronos CompositeSummary page 5…., AttraX Putty, cleared under K151584; Biostructures LLC, Signafuse Bioactive Bone Graft Putty; cleared under K132071; Synthes; chronOS Composite; cleared under K071046. The subject device and predicate devices K161859, K151584, K132071, and K071046 have the same intended use, the same product cla… | 2007 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211201 | MagnetOs Easypack Putty | 2021 | 3 |
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 2.3 years on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K211201 (Kuros Biosciences B.V, 2021) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K161859.
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?
MagnetOs Putty is an implant intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine. MagnetOs Putty must be used with autograft as a bone graft extender in the posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MagnetOs Putty resorbs and is replaced with bone during the healing process.
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/K171563 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171563: MagnetOs Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171563
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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