# K071046: Synthes Chronos Composite

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Oct 23, 2007 after 193 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K013072 (2002). 2 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043045: Synthes (Usa) Chronos, Synthes (Usa) (2005) Summary page 1.
- K013072: Chronos Tricalcium Prosphate (Chronos TCP), Synthes (2002)

## Most influential descendants
- K171563: MagnetOs Putty (2017), 4 descendants of its own
- K211201: MagnetOs Easypack Putty (2021), 3 descendants of its own
- K233607: MagnetOs Easypack Putty (2023), 2 descendants of its own
- K241212: MagnetOs Easypack Putty (2024), 1 descendant of its own
- K111944: NB3D Bone Void Filler (2011), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K071046
Methodology: https://510kreport.com/methodology