# K211201: MagnetOs Easypack Putty

- Pathway: 510(k) (Traditional)
- Applicant: Kuros Biosciences B.V
- Decided: Sep 2, 2021 after 133 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: 10 generations back to K960978 (1996). 55 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181958: MagnetOs Putty, Kuros Biosciences B.V (2018) Summary page 5.
- K171563: MagnetOs Putty, Kuros Biosciences B.V (2017) Summary page 5.
- K193075: Osteo3 ZP Putty, Sirakoss, Ltd. (2020) Summary page 5.
- K082575: Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft Substitutes, Apatech, Ltd. (2008) Summary page 5.
- K161859: MagnetOs, Xpand Biotechnology BV (2017) Summary page 5.

## Most influential descendants
- K233607: MagnetOs Easypack Putty (2023), 2 descendants of its own
- K241212: MagnetOs Easypack Putty (2024), 1 descendant of its own
- K243474: MagnetOs MIS (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K211201
Methodology: https://510kreport.com/methodology
