510(k) · Cleared
ClearedMagnetOs Easypack 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 Sep 2, 2021 as substantially equivalent to K181958 (Kuros Biosciences B.V, 2018) and 4 other predicates after a 133-day review. Its family tree reaches back 10 generations to 1996. 3 later devices descend from it.
- Decided
- Sep 2, 2021
- Review
- 133 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K960978 (1996). 55 ancestors in all, the oldest K871773 (1987). 3 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 6 generations between
- 3 generations backK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
- 2 generations backK140375 Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014
- 1 generation backK193075 Osteo3 ZP PuttySirakoss, Ltd. · 2020
- This deviceK211201 MagnetOs Easypack PuttyKuros Biosciences B.V · 2021
- Descendant · cites it directly · 2 of its ownK233607 MagnetOs Easypack PuttyKuros Biosciences B.V · 2023
- Descendant · 2 generations on · 1 of its ownK241212 MagnetOs Easypack PuttyKuros Biosciences · 2024
- Descendant · 3 generations on · 0 of its ownK243474 MagnetOs MISKuros Biosciences B.V · 2025
Show all 10 generations
- Root · 10 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 9 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 8 generations backK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
- 7 generations backK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
- 6 generations backK043308 Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005
- 5 generations backK051386 Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005
- 4 generations backK071813 Mastergraft PuttyMedtronic Sofamor Danek · 2007
- 3 generations backK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
- 2 generations backK140375 Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014
- 1 generation backK193075 Osteo3 ZP PuttySirakoss, Ltd. · 2020
- This deviceK211201 MagnetOs Easypack PuttyKuros Biosciences B.V · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −9 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −8 | K000515 | Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101… | Interpore Cross Intl. | 2000 | — |
| −7 | K012751 | Healos Bone Graft Material | Orquest, Inc. | 2001 | — |
| −6 | K043308 | Modification to: Healos Bone Graft Material | Depuy Spine, Inc. | 2005 | — |
| −5 | K051386 | Mastergraft Putty Bone Void Filler | Medtronic Vascular | 2005 | — |
| −4 | K071813 | Mastergraft Putty | Medtronic Sofamor Danek | 2007 | — |
| −3 | K082166 | Mastergraft Strip | Medtronic Sofamor Danek | 2009 | — |
| −2 | K140375 | Mastergraft Putty, Mastergraft Strip | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −1 | K193075 | Osteo3 ZP Putty | Sirakoss, Ltd. | 2020 | — |
| 0 (this device) | K211201 | MagnetOs Easypack Putty | Kuros Biosciences B.V | 2021 | — |
| +1 | K233607 | MagnetOs Easypack Putty | Kuros Biosciences B.V | 2023 | — |
| +2 | K241212 | MagnetOs Easypack Putty | Kuros Biosciences | 2024 | — |
| +3 | K243474 | MagnetOs MIS | Kuros Biosciences B.V | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K181958 | MagnetOs PuttySummary page 5…Easypack Putty is substantially equivalent in indications and design principles to the following cleared and legally marketed predicate devices: • MagnetOs Putty (K181958, K171563), the primary predicate, is highly similar to the subject device used for the comparison animal spine study. It… | 2018 |
| * | K171563 | MagnetOs PuttySummary page 5…Putty is substantially equivalent in indications and design principles to the following cleared and legally marketed predicate devices: • MagnetOs Putty (K181958, K171563), the primary predicate, is highly similar to the subject device used for the comparison animal spine study. It consists… | 2017 |
| * | K193075 | Osteo3 ZP PuttySummary page 5…on of the subject device, together with a synthetic polymeric binder, which is highly similar to the binder used in the subject device. • Osteo3 ZP Putty (K193075) is packed in identical primary packaging and is indicated for the same intended use as MagnetOs Easypack Putty. •… | 2020 |
| * | K082575 | Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft SubstitutesSummary page 5…Osteo3 ZP Putty (K193075) is packed in identical primary packaging and is indicated for the same intended use as MagnetOs Easypack Putty. • Actifuse ABX (K082575) is packed in comparable primary packaging and has similar indications for use, as a bone void filler in spine. •… | 2008 |
| * | K161859 | MagnetOsSummary page 5…packed in comparable primary packaging and has similar indications for use, as a bone void filler in spine. • MagnetOs Granules (Xpand Biotechnology B.V., K161859) is cleared for the same intended use as MagnetOs Easypack Putty. Identical MagnetOs granules are present in Magn… | 2017 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233607 | MagnetOs Easypack Putty | 2023 | 2 |
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 25 years and passes through 10 companies; a new generation was cleared every 2.0 years on median.
- 6 of the 55 ancestors have a recall of any class.
- Of its descendants, K233607 (Kuros Biosciences B.V, 2023) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K181958.
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. 2021, 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 Easypack Putty is intended to fill bony voids or gaps of the skeletal system, i.e. posterolateral spine. In the posterolateral spine, MagnetOs Easypack Putty must be used with autograft as a bone graft extender. The 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 Easypack 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/K211201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211201: MagnetOs Easypack Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211201
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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