# K181958: MagnetOs Putty

- Pathway: 510(k) (Traditional)
- Applicant: Kuros Biosciences B.V
- Decided: Dec 6, 2018 after 136 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 K082575 (2008). 1 ancestor in all.
10 later devices descend from it; 3 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)
- K082575: Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft Substitutes, Apatech, Ltd. (2008) Summary page 5.

## Most influential descendants
- K213111: MagnetOs granules (2022), 7 descendants of its own
- K230736: MagnetOs Putty (2023), 4 descendants of its own
- K240442: MagnetOs Putty (2024), 3 descendants of its own
- K211201: MagnetOs Easypack Putty (2021), 3 descendants of its own
- K233607: MagnetOs Easypack Putty (2023), 2 descendants of its own

## Indications for use
MagnetOs Putty is an implant intended to fill bony voids or gaps of the skeletal system i.e., the extremities, pelvis and posterolateral spine. In the posterolateral spine, MagnetOs Putty must-be-used-with autograft as bone graft extender, In extremities and pelvis, MagnetOs Putty is used alone. 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 resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K181958
Methodology: https://510kreport.com/methodology