# K233245: MagnetOs Flex Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Kuros Biosciences B.V
- Decided: Nov 21, 2023 after 54 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: 25 generations back to K841189 (1984). 309 ancestors in all.
No later device cites it as a predicate yet.
1 of 310 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203714: NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty, Nu Vasive, Incorporated (2021) Summary page 5.

## Indications for use
Magnetos Flex Matrix is intended to fill bony voids or gaps of the skeletal system, i.e., the intervertebral disc space, and posterolateral spine. 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. In the intervertebral disc space and posterolateral spine, Magnetos Flex Matrix must be hydrated with bone marrow aspirate (BMA) and used as an extender to autograft bone. When used in intervertebral body fusion procedures, Magnetos Flex Matrix must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. Magnetos Flex Matrix resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K233245
Methodology: https://510kreport.com/methodology