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 Dec 6, 2018 as substantially equivalent to K082575 (Apatech, Ltd., 2008) after a 136-day review. Its family tree reaches back 1 generation to 2008. 10 later devices descend from it.
- Decided
- Dec 6, 2018
- Review
- 136 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082575 (2008). 10 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK082575 Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft…Apatech, Ltd. · 2008 · Recalled
- This deviceK181958 MagnetOs PuttyKuros Biosciences B.V · 2018
- Descendant · cites it directly · 7 of its ownK213111 MagnetOs granulesKuros Biosciences B.V · 2022
- Descendant · cites it directly · 4 of its ownK230736 MagnetOs PuttyKuros Biosciences B.V · 2023
- Descendant · 2 generations on · 3 of its ownK240442 MagnetOs PuttyKuros Biosciences B.V · 2024
- 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
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K213111MagnetOs granulesKuros Biosciences B.V · 2022 · cites it directly7descendants
- K230736MagnetOs PuttyKuros Biosciences B.V · 2023 · cites it directly4descendants
- K240442MagnetOs PuttyKuros Biosciences B.V · 2024 · 2 generations on3descendants
- K211201MagnetOs Easypack PuttyKuros Biosciences B.V · 2021 · cites it directly3descendants
- K233607MagnetOs Easypack PuttyKuros Biosciences B.V · 2023 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082575 | Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft Substitutes | Apatech, Ltd. | 2008 | 1 |
| 0 (this device) | K181958 | MagnetOs Putty | Kuros Biosciences B.V | 2018 | — |
| +1 | K213111 | MagnetOs granules | Kuros Biosciences B.V | 2022 | — |
| +1 | K230736 | MagnetOs Putty | Kuros Biosciences B.V | 2023 | — |
| +2 | K240442 | MagnetOs Putty | Kuros Biosciences B.V | 2024 | — |
| +1 | K211201 | MagnetOs Easypack Putty | Kuros Biosciences B.V | 2021 | — |
| +2 | K233607 | MagnetOs Easypack Putty | Kuros Biosciences B.V | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082575 | Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft SubstitutesSummary page 5…Baxter BV 510k No K082575 K082575 Device… | 2008 |
What descends from it? (10)
3 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?
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. 2018, 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., the extremities, pelvis and posterolateral spine. In the posterolateral spine, MagnetOs Putty must-be-used-with autograft as bone graft extender, In extremities and pelvis, MagnetOs Putty is used alone. 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/K181958 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181958: 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/K181958
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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