510(k) Report

510(k) · Cleared

Cleared

MagnetOs Putty

K240442510(k) TraditionalCleared Apr 1, 202447-day reviewClass II21 CFR 888.3045

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kuros Biosciences B.V · MQV Filler, Bone Void, Calcium Compound

Cleared on Apr 1, 2024 as substantially equivalent to K203714 (Nu Vasive, Incorporated, 2021) and 1 other predicate after a 47-day review. Its family tree reaches back 25 generations to 1984. 1 of the 321 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.

Decided
Apr 1, 2024
Review
47 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
2

Its longest line of descent runs back 25 generations to K841189 (1984). 317 ancestors in all. 3 later devices descend from it, 3 citing it directly. 1 of the 321 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2023: 1 other ancestor2022: 1 other ancestor2020: 3 other ancestors2019: 2 other ancestors2018: 3 other ancestors2017: 6 other ancestors2016: 4 other ancestors2015: 13 other ancestors2014: 15 other ancestors2010: 18 other ancestors2009: 24 other ancestors2008: 41 other ancestors, 1 with a Class I recall12007: 16 other ancestors2013: 13 other ancestors2012: 11 other ancestors2011: 20 other ancestors2003: 18 other ancestors2002: 12 other ancestors2000: 3 other ancestors2006: 8 other ancestors2005: 18 other ancestors2004: 24 other ancestors1999: 3 other ancestors1998: 1 other ancestor1996: 3 other ancestors2001: 10 other ancestors1997: 1 other ancestor2024: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011K121683 · Acculif TL Cage · Coalign Innovations, Inc. · 2012K123752 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013K132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalledK141217 · Acculif TL and PL Cage · Stryker Corporation · 2014 · recalledK143163 · AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System · Stryker Corporation · 2015×2: 2 generations cleared close together, K153782 (2016), K161230 (2016) ×3: 3 generations cleared close together, K170962 (2017), K171633 (2017), K172341 (2017) K193593 · NuVasive 3DP Interfixated ALIF System · Nu Vasive, Incorporated · 2020K201820 · NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System · Nu Vasive, Incorporated · 2020K203714 · NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty · Nu Vasive, Incorporated · 202119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 5 other ancestors3 generations back: 17 other ancestors4 generations back: 33 other ancestors5 generations back: 54 other ancestors6 generations back: 87 other ancestors, 1 with a Class I recall17 generations back: 33 other ancestors8 generations back: 39 other ancestors9 generations back: 18 other ancestors10 generations back: 5 other ancestors 1 generation forward: 3 descendants K203714 · NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty · Nu Vasive, Incorporated · 2021K201820 · NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System · Nu Vasive, Incorporated · 2020K193593 · NuVasive 3DP Interfixated ALIF System · Nu Vasive, Incorporated · 2020K172341 · NuVasive® Modulus TLIF Interbody System · Nu Vasive, Incorporated · 2017K171633 · NuVasive TLX Interbody System · Nu Vasive, Incorporated · 2017K170962 · NuVasive® CoRoent® Thoracolumbar System · Nu Vasive, Incorporated · 2017K161230 · NuVasive Lumbar Interbody Implants · Nu Vasive, Incorporated · 2016K153782 · NuVasive® Lumbar Interbody Implants · Nu Vasive, Incorporated · 2016K143163 · AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System · Stryker Corporation · 2015K141217 · Acculif TL and PL Cage · Stryker Corporation · 2014 · recalledK132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalledK123752 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013K121683 · Acculif TL Cage · Coalign Innovations, Inc. · 2012K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−25−20−15−10−50
  1. Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 21 generations between
  3. 3 generations backK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
  4. 2 generations backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
  5. 1 generation backK203714 NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent…Nu Vasive, Incorporated · 2021
  6. This deviceK240442 MagnetOs PuttyKuros Biosciences B.V · 2024
  7. Descendant · cites it directly · 1 of its ownK241212 MagnetOs Easypack PuttyKuros Biosciences · 2024
  8. Descendant · cites it directly · 0 of its ownK262230 Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc. · 2026
  9. Descendant · cites it directly · 0 of its ownK243474 MagnetOs MISKuros Biosciences B.V · 2025
Show all 25 generations
  1. Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 24 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 23 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 22 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 21 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 20 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 19 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 18 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 17 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 16 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. 15 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
  12. 14 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
  13. 13 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
  14. 12 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
  15. 11 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
  16. 10 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
  17. 9 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
  18. 8 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
  19. 7 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
  20. 6 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
  21. 5 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
  22. 4 generations backK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
  23. 3 generations backK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
  24. 2 generations backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
  25. 1 generation backK203714 NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent…Nu Vasive, Incorporated · 2021
  26. This deviceK240442 MagnetOs PuttyKuros Biosciences B.V · 2024

Class I recalls in this family

Most influential descendants

Showing 3 of 3 · See all
  • K241212MagnetOs Easypack PuttyKuros Biosciences · 2024 · cites it directly1descendant
  • K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc. · 2026 · cites it directly0descendants
  • K243474MagnetOs MISKuros Biosciences B.V · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−25K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−24K990148Stackable Cage SystemDepuy Motech Acromed1999—
−23K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−22K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−21K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−20K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−19K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−18K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−17K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−16K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
−15K094025Crescent Spinal SystemMedtronic Sofamor Danek2010—
−14K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011—
−13K121683Acculif TL CageCoalign Innovations, Inc.2012—
−12K123752Acculif TL and PL CageCoalign Innovations, Inc.2013—
−11K132505Acculif TL and PL CageCoalign Innovations, Inc.20133
−10K141217Acculif TL and PL CageStryker Corporation20143
−9K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK…Stryker Corporation2015—
−8K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016—
−7K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016—
−6K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017—
−5K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017—
−4K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017—
−3K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020—
−2K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System…Nu Vasive, Incorporated2020—
−1K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar…Nu Vasive, Incorporated2021—
0 (this device)K240442MagnetOs PuttyKuros Biosciences B.V2024—
+1K241212MagnetOs Easypack PuttyKuros Biosciences2024—
+1K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.2026—
+1K243474MagnetOs MISKuros Biosciences B.V2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199630
199710
199810
199930
200030
2001100
2002120
2003180
2004240
2005180
200680
2007160
2008411
2009240
2010180
2011200
2012110
2013130
2014150
2015130
201640
201760
201830
201920
202030
202210
202310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
202510
202610
FIG. 1 — Lineage of K240442, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K232315 Catalyst Bone Void Fillerscore 25.2 · 25 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…
Summary page 5
…: 21 CFR 888.3045 Class: II Product Codes: MQV Primary Predicate: NuVasive Attrax Putty, NuVasive, Inc., K203714 Additional Predicate: MagnetOs Putty, Kuros Biosciences B.V, K230736 Indications For Use: MagnetOs Putty is an implant…
Nu Vasive, Incorporated2021—
*K230736MagnetOs Putty
Summary page 5
…s: MQV Primary Predicate: NuVasive Attrax Putty, NuVasive, Inc., K203714 Additional Predicate: MagnetOs Putty, Kuros Biosciences B.V, K230736 Indications For Use: MagnetOs Putty is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the extremit…
Kuros Biosciences B.V2023—

Also cleared against K203714: 30 other devices →

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K241212MagnetOs Easypack PuttyKuros Biosciences20241
K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260
K243474MagnetOs MISKuros Biosciences B.V20250

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 · 6 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 13 companies; a new generation was cleared every 10 months on median.
  • 36 of the 317 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K241212 (Kuros Biosciences, 2024) has gone furthest, with 1 descendant of its own.
  • 30 other devices also cite its predicate K203714.

How does its category compare?

All MQV devices

MQV 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

2007: 352008: 322009: 232010: 172011: 162012: 92013: 122014: 202015: 182016: 82017: 172018: 232019: 132020: 152021: 82022: 92023: 212024: 282025: 142026 (partial year): 5
2007high 35 (2007) · low 8 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQV

57in 2025

2007: 144 days median2008: 102 days median2009: 180 days median2010: 147 days median2011: 92 days median2012: 107 days median2013: 197 days median2014: 153 days median2015: 184 days median2016: 214 days median2017: 124 days median2018: 124 days median2019: 90 days median2020: 132 days median2021: 88 days median2022: 118 days median2023: 74 days median2024: 55 days median2025: 57 days median2026 (partial year): 96 days median
2007high 214 (2016) · low 55 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQV

1in 2025

2007: 52008: 32009: 12011: 62012: 32013: 22016: 12017: 12018: 22020: 12023: 32024: 22025: 12026 (partial year): 4
2007high 6 (2011) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQV

57in 2025

2007: 672008: 712009: 812010: 682011: 1142012: 1492013: 2232014: 1112015: 1252016: 1062017: 1072018: 862019: 652020: 1262021: 1012022: 472023: 1202024: 682025: 57
2007high 223 (2013) · low 47 (2022)2025

MAUDE reports naming product code MQV, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735144567
200832102371
200923180181
201017147068
201116926114
201291073149
2013121972223
2014201530111
2015181840125
201682141106
2017171241107
201823124286
20191390065
2020151321126
20218880101
20229118047
202321743120
20242855268
20251457157
20265964—

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, intervertebral disc space, and 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 Putty may be used standalone or mixed with autograft. When used in intervertebral body fusion procedures, MagnetOs Putty must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. 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.

Cite this page

510(k) Report. “K240442: 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/K240442

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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