# K161859: MagnetOs

- Pathway: 510(k) (Traditional)
- Applicant: Xpand Biotechnology BV
- Decided: Feb 24, 2017 after 233 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: 4 generations back to K960978 (1996). 9 ancestors in all.
12 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090641: Curios, Progentix Orthobiology BV (2009) Summary page 5.
- K032268: MBCP, Biomatlante (2003) Summary page 5.
- K030131: Ossatura BCP Bone Void Filler, Isotis NV (2003) Summary page 5.

## Most influential descendants
- K213111: MagnetOs granules (2022), 7 descendants of its own
- K230736: MagnetOs Putty (2023), 4 descendants of its own
- K171563: MagnetOs Putty (2017), 4 descendants of its own
- K240442: MagnetOs Putty (2024), 3 descendants of its own
- K211201: MagnetOs Easypack Putty (2021), 3 descendants of its own

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

Source page: https://510kreport.com/device/K161859
Methodology: https://510kreport.com/methodology