510(k) · Cleared
ClearedSynthes (Usa) Chronos
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · MQV Filler, Bone Void, Calcium Compound
Cleared on Jan 7, 2005 after a 64-day review. The FDA summary names its predicate without a number. 13 later devices descend from it.
- Decided
- Jan 7, 2005
- Review
- 64 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 5 citing it directly.
- This deviceK043045 Synthes (Usa) ChronosSynthes (Usa) · 2005
- Descendant · cites it directly · 9 of its ownK071046 Synthes Chronos CompositeSynthes (Usa) · 2007
- Descendant · 2 generations on · 4 of its ownK171563 MagnetOs PuttyKuros Biosciences B.V · 2017
- Descendant · 3 generations on · 3 of its ownK211201 MagnetOs Easypack PuttyKuros Biosciences B.V · 2021
- Descendant · 4 generations on · 2 of its ownK233607 MagnetOs Easypack PuttyKuros Biosciences B.V · 2023
- Descendant · 5 generations on · 1 of its ownK241212 MagnetOs Easypack PuttyKuros Biosciences · 2024
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K071046Synthes Chronos CompositeSynthes (Usa) · 2007 · cites it directly9descendants
- K171563MagnetOs PuttyKuros Biosciences B.V · 2017 · 2 generations on4descendants
- K211201MagnetOs Easypack PuttyKuros Biosciences B.V · 2021 · 3 generations on3descendants
- K233607MagnetOs Easypack PuttyKuros Biosciences B.V · 2023 · 4 generations on2descendants
- K241212MagnetOs Easypack PuttyKuros Biosciences · 2024 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043045 | Synthes (Usa) Chronos | Synthes (Usa) | 2005 | — |
| +1 | K071046 | Synthes Chronos Composite | Synthes (Usa) | 2007 | — |
| +2 | K171563 | MagnetOs Putty | Kuros Biosciences B.V | 2017 | — |
| +3 | K211201 | MagnetOs Easypack Putty | Kuros Biosciences B.V | 2021 | — |
| +4 | K233607 | MagnetOs Easypack Putty | Kuros Biosciences B.V | 2023 | — |
| +5 | K241212 | MagnetOs Easypack Putty | Kuros Biosciences | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | — | Synthes chronOS Named without a submission number | |
| * | — | Orthovita, Inc. Vitoss Scaffold Synthetic Cancellous Bone Void Filler Named without a submission number | |
| * | — | Imbibe II Syringe Named without a submission number |
What descends from it? (13)
See all 135 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?
- Of its descendants, K071046 (Synthes (Usa), 2007) has gone furthest, with 9 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.
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?
Synthes ebronOSTM is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony strueture. Synthes chronOSTM is indicated for use in the treatment of bony defects created surgically or through traumatic injury.
Synthes chronOS M is intended to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement into the bony void, chronOSTM resorb? and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043045 · printed Nov 3, 2026
Cite this page
510(k) Report. “K043045: Synthes (Usa) Chronos.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K043045
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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