# K213959: MagnetOs Flex Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Kuros Biosciences B.V
- Decided: Apr 14, 2022 after 118 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). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082166: Mastergraft Strip, Medtronic Sofamor Danek (2009) Summary page 6.
- K032288: Vitoss Scaffold Foam Bone Graft Material, Orthovita, Inc. (2003) Summary page 6.
- K161859: MagnetOs, Xpand Biotechnology BV (2017) Summary page 6.

## Indications for use
MagnetOs Flex Matrix is intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine. In the posterolateral spine, MagnetOs Flex Matrix must be hydrated with bone marrow aspirate and used as an extender to autograft bone. 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 Flex Matrix resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K213959
Methodology: https://510kreport.com/methodology