510(k) · Cleared
ClearedMagnetOs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xpand Biotechnology BV · MQV Filler, Bone Void, Calcium Compound
Cleared on Feb 24, 2017 as substantially equivalent to K090641 (Progentix Orthobiology BV, 2009) and 2 other predicates after a 233-day review. Its family tree reaches back 4 generations to 1996. 12 later devices descend from it.
- Decided
- Feb 24, 2017
- Review
- 233 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K960978 (1996). 9 ancestors in all. 12 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 3 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 2 generations backK030131 Ossatura BCP Bone Void FillerIsotis NV · 2003
- 1 generation backK090641 CuriosProgentix Orthobiology BV · 2009
- This deviceK161859 MagnetOsXpand Biotechnology BV · 2017
- Descendant · cites it directly · 7 of its ownK213111 MagnetOs granulesKuros Biosciences B.V · 2022
- Descendant · 2 generations on · 4 of its ownK230736 MagnetOs PuttyKuros Biosciences B.V · 2023
- Descendant · cites it directly · 4 of its ownK171563 MagnetOs PuttyKuros Biosciences B.V · 2017
- Descendant · 3 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
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K213111MagnetOs granulesKuros Biosciences B.V · 2022 · cites it directly7descendants
- K230736MagnetOs PuttyKuros Biosciences B.V · 2023 · 2 generations on4descendants
- K171563MagnetOs PuttyKuros Biosciences B.V · 2017 · cites it directly4descendants
- K240442MagnetOs PuttyKuros Biosciences B.V · 2024 · 3 generations on3descendants
- K211201MagnetOs Easypack PuttyKuros Biosciences B.V · 2021 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −3 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −2 | K030131 | Ossatura BCP Bone Void Filler | Isotis NV | 2003 | — |
| −1 | K090641 | Curios | Progentix Orthobiology BV | 2009 | — |
| 0 (this device) | K161859 | MagnetOs | Xpand Biotechnology BV | 2017 | — |
| +1 | K213111 | MagnetOs granules | Kuros Biosciences B.V | 2022 | — |
| +2 | K230736 | MagnetOs Putty | Kuros Biosciences B.V | 2023 | — |
| +1 | K171563 | MagnetOs Putty | Kuros Biosciences B.V | 2017 | — |
| +3 | K240442 | MagnetOs Putty | Kuros Biosciences B.V | 2024 | — |
| +1 | K211201 | MagnetOs Easypack Putty | Kuros Biosciences B.V | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K090641 | CuriosSummary page 5…ubstantially equivalent in indications and design principles to the following legally marketed predicate devices: Progentix Orthobiology B.V., CuriOs™, cleared under K090641; Biomatlante SA, MBCP, cleared under K032268, and IsoTis N.V., OsSatura™ BCP, cleared under K030131. The subject device a… | 2009 |
| * | K032268 | MBCPSummary page 5…principles to the following legally marketed predicate devices: Progentix Orthobiology B.V., CuriOs™, cleared under K090641; Biomatlante SA, MBCP, cleared under K032268, and IsoTis N.V., OsSatura™ BCP, cleared under K030131. The subject device and predicate devices K090641, K032268 and K030131… | 2003 |
| * | K030131 | Ossatura BCP Bone Void FillerSummary page 5…ices: Progentix Orthobiology B.V., CuriOs™, cleared under K090641; Biomatlante SA, MBCP, cleared under K032268, and IsoTis N.V., OsSatura™ BCP, cleared under K030131. The subject device and predicate devices K090641, K032268 and K030131 have the same intended use, the same product classificatio… | 2003 |
What descends from it? (12)
See all 124 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 21 years and passes through 5 companies; a new generation was cleared every 6.4 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K213111 (Kuros Biosciences B.V, 2022) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K090641.
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 is an implant intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine. MagnetOs 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 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/K161859 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161859: MagnetOs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161859
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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