510(k) · Cleared
ClearedMagnetOs granules
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 Jan 10, 2022 as substantially equivalent to K191974 (Nu Vasive, Incorporated, 2019) and 3 other predicates after a 108-day review. Its family tree reaches back 8 generations to 1996. 7 later devices descend from it.
- Decided
- Jan 10, 2022
- Review
- 108 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K960978 (1996). 20 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 7 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 6 generations backK030131 Ossatura BCP Bone Void FillerIsotis NV · 2003
- 5 generations backK040082 Pore-SI Bone Graft SubstituteApatech, Ltd. · 2004
- 4 generations backK071206 Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteApatech, Ltd. · 2007 · Recalled
- 3 generations backK080736 Actifuse Shape Bone Graft SubstituteApatech, Ltd. · 2008
- 2 generations backK151584 AttraX PuttyProgentix Orthobiology BV · 2015
- 1 generation backK191974 NuVasive AttraX PuttyNu Vasive, Incorporated · 2019
- This deviceK213111 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 · 3 generations on · 1 of its ownK241212 MagnetOs Easypack PuttyKuros Biosciences · 2024
- Descendant · cites it directly · 1 of its ownK223915 TactosetAnika Therapeutics, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK262230 Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K230736MagnetOs PuttyKuros Biosciences B.V · 2023 · cites it directly4descendants
- K240442MagnetOs PuttyKuros Biosciences B.V · 2024 · 2 generations on3descendants
- K241212MagnetOs Easypack PuttyKuros Biosciences · 2024 · 3 generations on1descendant
- K223915TactosetAnika Therapeutics, Inc. · 2023 · cites it directly1descendant
- K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −7 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −6 | K030131 | Ossatura BCP Bone Void Filler | Isotis NV | 2003 | — |
| −5 | K040082 | Pore-SI Bone Graft Substitute | Apatech, Ltd. | 2004 | — |
| −4 | K071206 | Actifuse Abx E-Z-Fil Putty Bone Graft Substitute | Apatech, Ltd. | 2007 | 1 |
| −3 | K080736 | Actifuse Shape Bone Graft Substitute | Apatech, Ltd. | 2008 | — |
| −2 | K151584 | AttraX Putty | Progentix Orthobiology BV | 2015 | — |
| −1 | K191974 | NuVasive AttraX Putty | Nu Vasive, Incorporated | 2019 | — |
| 0 (this device) | 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 | — |
| +3 | K241212 | MagnetOs Easypack Putty | Kuros Biosciences | 2024 | — |
| +1 | K223915 | Tactoset | Anika Therapeutics, Inc. | 2023 | — |
| +3 | K262230 | Mg OSTEOREVIVE™;Mg OSTEOCRETE™ | Bone Solutions, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 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? (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 |
|---|---|---|---|
| * | K191974 | NuVasive AttraX PuttySummary page 4…e calcium salt bone void filler device Class: 21 CFR 888.3045, Class II Product Code: MQV Primary Predicate: NuVasive AttraX Putty (K191974) Additional Predicates: MagnetOs Granules (K161859) MagnetOs Putty (K181958)… | 2019 |
| * | K161859 | MagnetOsSummary page 4…21 CFR 888.3045, Class II Product Code: MQV Primary Predicate: NuVasive AttraX Putty (K191974) Additional Predicates: MagnetOs Granules (K161859) MagnetOs Putty (K181958) Actifuse Bone graft Substitute (K082575)… | 2017 |
| * | K181958 | MagnetOs PuttySummary page 4…MQV Primary Predicate: NuVasive AttraX Putty (K191974) Additional Predicates: MagnetOs Granules (K161859) MagnetOs Putty (K181958) Actifuse Bone graft Substitute (K082575) Synthes ChronOS (K043045)… | 2018 |
| * | K082575 | Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft SubstitutesSummary page 4…1974) Additional Predicates: MagnetOs Granules (K161859) MagnetOs Putty (K181958) Actifuse Bone graft Substitute (K082575) Synthes ChronOS (K043045)… | 2008 |
What descends from it? (7)
2 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?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 20 ancestors have a recall of any class.
- Of its descendants, K230736 (Kuros Biosciences B.V, 2023) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K191974.
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. 2022, 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 Granules is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the extremities, pelvis and posterolateral spine. MagnetOs Granules may be used standalone or mixed with autograft, blood, and/or bone marrow. 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 Granules resorbs and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213111 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213111: MagnetOs granules.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213111
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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