# K043045: Synthes (Usa) Chronos

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jan 7, 2005 after 64 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
No predicates in its family tree.
13 later devices descend from it; 5 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes chronOS: named in the summary without a submission number
- (no number) Orthovita, Inc. Vitoss Scaffold Synthetic Cancellous Bone Void Filler: named in the summary without a submission number
- (no number) Imbibe II Syringe: named in the summary without a submission number

## Most influential descendants
- K071046: Synthes Chronos Composite (2007), 9 descendants of its own
- 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

## Indications for use
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.

Source page: https://510kreport.com/device/K043045
Methodology: https://510kreport.com/methodology