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 · MQV Filler, Bone Void, Calcium Compound
Cleared on Jun 27, 2024 as substantially equivalent to K233490 (Bioventus, LLC, 2023) and 3 other predicates after a 58-day review. Its family tree reaches back 27 generations to 1984. 1 of the 420 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jun 27, 2024
- Review
- 58 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 27 generations to K841189 (1984). 418 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 420 devices in this family, counting this one, has a Class I recall.
- Root · 27 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 23 generations between
- 3 generations backK203714 NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent…Nu Vasive, Incorporated · 2021
- 2 generations backK222276 CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022
- 1 generation backK233490 SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC · 2023
- This deviceK241212 MagnetOs Easypack PuttyKuros Biosciences · 2024
- Descendant · cites it directly · 0 of its ownK243474 MagnetOs MISKuros Biosciences B.V · 2025
Show all 27 generations
- Root · 27 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 26 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 25 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 24 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 23 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 22 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 21 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 20 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 19 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 18 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 17 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 16 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 15 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 14 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 13 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 12 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 11 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 10 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 9 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 8 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 7 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 6 generations backK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
- 5 generations backK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
- 4 generations backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
- 3 generations backK203714 NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent…Nu Vasive, Incorporated · 2021
- 2 generations backK222276 CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022
- 1 generation backK233490 SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC · 2023
- This deviceK241212 MagnetOs Easypack PuttyKuros Biosciences · 2024
Class I recalls in this family
- K073202 Ardis Spacer7 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K243474MagnetOs MISKuros Biosciences B.V · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −27 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −26 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −25 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −24 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −23 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −22 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −21 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −20 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −19 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −18 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −17 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −16 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −15 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −14 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −13 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −12 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −11 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −10 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −9 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −8 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −7 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −6 | K172341 | NuVasive® Modulus TLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −5 | K193593 | NuVasive 3DP Interfixated ALIF System | Nu Vasive, Incorporated | 2020 | — |
| −4 | K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System… | Nu Vasive, Incorporated | 2020 | — |
| −3 | K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar… | Nu Vasive, Incorporated | 2021 | — |
| −2 | K222276 | CONDUIT Cages; FIBERGRAFT BG Putty | Depuy Spine | 2022 | — |
| −1 | K233490 | SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty | Bioventus, LLC | 2023 | — |
| 0 (this device) | K241212 | MagnetOs Easypack Putty | Kuros Biosciences | 2024 | — |
| +1 | K243474 | MagnetOs MIS | Kuros Biosciences B.V | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 14 | 0 |
| 2002 | 15 | 0 |
| 2003 | 20 | 0 |
| 2004 | 29 | 0 |
| 2005 | 26 | 0 |
| 2006 | 11 | 0 |
| 2007 | 19 | 0 |
| 2008 | 46 | 1 |
| 2009 | 30 | 0 |
| 2010 | 22 | 0 |
| 2011 | 28 | 0 |
| 2012 | 11 | 0 |
| 2013 | 16 | 0 |
| 2014 | 25 | 0 |
| 2015 | 17 | 0 |
| 2016 | 6 | 0 |
| 2017 | 11 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K233490 | SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttySummary page 5…void filler Class: 21 CFR 888.3045, Class II Product Code: MQV Primary Predicate: SIGNAFUSE Putty (K233490) Additional Predicates: MagnetOs Putty (K240442) MagnetOs Easypack Putty (K233… | 2023 |
| * | K240442 | MagnetOs PuttySummary page 5…45, Class II Product Code: MQV Primary Predicate: SIGNAFUSE Putty (K233490) Additional Predicates: MagnetOs Putty (K240442) MagnetOs Easypack Putty (K233607) MagnetOs Granules (K… | 2024 |
| * | K233607 | MagnetOs Easypack PuttySummary page 5…e: SIGNAFUSE Putty (K233490) Additional Predicates: MagnetOs Putty (K240442) MagnetOs Easypack Putty (K233607) MagnetOs Granules (K232347) Indications For Use: MagnetOs Easypack Putty is intended to… | 2023 |
| * | K232347 | MagnetOs GranulesSummary page 5…tes: MagnetOs Putty (K240442) MagnetOs Easypack Putty (K233607) MagnetOs Granules (K232347) Indications For Use: MagnetOs Easypack Putty is intended to fill bony voids or gaps of the skeletal system, i.e., the extrem… | 2024 |
| † | K211201 | MagnetOs Easypack Putty | 2021 |
| † | K181958 | MagnetOs Putty | 2018 |
| † | K230736 | MagnetOs Putty | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243474 | MagnetOs MIS | 2025 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 7 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 40 years and passes through 15 companies; a new generation was cleared every 10 months on median.
- 44 of the 418 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K243474 (Kuros Biosciences B.V, 2025) has gone furthest, with 0 descendants of its own.
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. 2024, 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., the extremities, pelvis, intervertebral disc space, and posterolateral spine. 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. In the extremities, pelvis, intervertebral disc space and posterolateral spine, MagnetOs Easypack Putty may be used standalone or…
Read the full statement (119 words)
MagnetOs Easypack Putty is intended to fill bony voids or gaps of the skeletal system, i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine. 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. In the extremities, pelvis, intervertebral disc space and posterolateral spine, MagnetOs Easypack Putty may be used standalone or with autograft as a bone extender. When used in intervertebral body fusion procedures, MagnetOs Easypack Putty must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
MagnetOs Easypack Putty resorbs and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241212: 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/K241212
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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