510(k) · Cleared
ClearedSynthes Chronos Composite
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 Oct 23, 2007 as substantially equivalent to K043045 (Synthes (Usa), 2005) and 1 other predicate after a 193-day review. Its family tree reaches back 1 generation to 2002. 9 later devices descend from it.
- Decided
- Oct 23, 2007
- Review
- 193 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K013072 (2002). 2 ancestors in all. 9 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK013072 Chronos Tricalcium Prosphate (Chronos TCP)Synthes · 2002
- This deviceK071046 Synthes Chronos CompositeSynthes (Usa) · 2007
- Descendant · cites it directly · 4 of its ownK171563 MagnetOs PuttyKuros Biosciences B.V · 2017
- Descendant · 2 generations on · 3 of its ownK211201 MagnetOs Easypack PuttyKuros Biosciences B.V · 2021
- Descendant · 3 generations on · 2 of its ownK233607 MagnetOs Easypack PuttyKuros Biosciences B.V · 2023
- Descendant · 4 generations on · 1 of its ownK241212 MagnetOs Easypack PuttyKuros Biosciences · 2024
- Descendant · cites it directly · 1 of its ownK111944 NB3D Bone Void FillerPioneer Surgical Technology, Inc. · 2011
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K171563MagnetOs PuttyKuros Biosciences B.V · 2017 · cites it directly4descendants
- K211201MagnetOs Easypack PuttyKuros Biosciences B.V · 2021 · 2 generations on3descendants
- K233607MagnetOs Easypack PuttyKuros Biosciences B.V · 2023 · 3 generations on2descendants
- K241212MagnetOs Easypack PuttyKuros Biosciences · 2024 · 4 generations on1descendant
- K111944NB3D Bone Void FillerPioneer Surgical Technology, Inc. · 2011 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013072 | Chronos Tricalcium Prosphate (Chronos TCP) | Synthes | 2002 | — |
| 0 (this device) | K071046 | Synthes Chronos Composite | Synthes (Usa) | 2007 | — |
| +1 | K171563 | MagnetOs Putty | Kuros Biosciences B.V | 2017 | — |
| +2 | K211201 | MagnetOs Easypack Putty | Kuros Biosciences B.V | 2021 | — |
| +3 | K233607 | MagnetOs Easypack Putty | Kuros Biosciences B.V | 2023 | — |
| +4 | K241212 | MagnetOs Easypack Putty | Kuros Biosciences | 2024 | — |
| +1 | K111944 | NB3D Bone Void Filler | Pioneer Surgical Technology, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043045 | Synthes (Usa) ChronosSummary page 1…FR § 888.3045 Product Code: IMQV Common Name: Resorbable Calcium Salt Bone Void Filler Predicate Devices: Synthes (USA) chronOS TM (K043045) chronOS TCP (KO13072) Intended Use: Synthes chronOS Composite is indicated for bony… | 2005 |
| * | K013072 | Chronos Tricalcium Prosphate (Chronos TCP) | 2002 |
What descends from it? (9)
4 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?
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. 2007, 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?
Synthes chronOS Composite is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Synthes chronOS Composite is indicated for use in the treatment of bony defects created surgically or through traumatic injury.
Synthes chronOS Composite, combined with autogenous blood and/or bone marrow or autograft, is intended to be used in spine for posterolateral fusion. Following placement into the bony void, chronOS Composite resorbs and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071046 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071046: Synthes Chronos Composite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071046
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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