# K213111: MagnetOs granules

- Pathway: 510(k) (Traditional)
- Applicant: Kuros Biosciences B.V
- Decided: Jan 10, 2022 after 108 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: 8 generations back to K960978 (1996). 20 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191974: NuVasive AttraX Putty, Nu Vasive, Incorporated (2019) Summary page 4.
- K161859: MagnetOs, Xpand Biotechnology BV (2017) Summary page 4.
- K181958: MagnetOs Putty, Kuros Biosciences B.V (2018) Summary page 4.
- K082575: Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft Substitutes, Apatech, Ltd. (2008) Summary page 4.

## Most influential descendants
- K230736: MagnetOs Putty (2023), 4 descendants of its own
- K240442: MagnetOs Putty (2024), 3 descendants of its own
- K241212: MagnetOs Easypack Putty (2024), 1 descendant of its own
- K223915: Tactoset (2023), 1 descendant of its own
- K262230: Mg OSTEOREVIVE™;Mg OSTEOCRETE™ (2026), 0 descendants of its own

## Indications for use
MagnetOs Granules is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the extremities, pelvis and posterolateral spine. MagnetOs Granules may be used standalone or mixed with autograft, blood, and/or bone marrow. 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 Granules resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K213111
Methodology: https://510kreport.com/methodology