# K243474: MagnetOs MIS

- Pathway: 510(k) (Traditional)
- Applicant: Kuros Biosciences B.V
- Decided: May 23, 2025 after 196 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: 28 generations back to K841189 (1984). 420 ancestors in all.
No later device cites it as a predicate yet.
1 of 421 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242299: NovaBone Putty - Synthetic Bioactive Bone Graft, Novabone Products, LLC (2024) Summary page 5.
- K241212: MagnetOs Easypack Putty, Kuros Biosciences (2024) Summary page 5.
- K240442: MagnetOs Putty, Kuros Biosciences B.V (2024) Summary page 5.

## Indications for use
MagnetOs MIS is intended to fill bony voids or gaps of the skeletal system, i.e., the extremities, pelvis, 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 extremities, pelvis, intervertebral disc space and posterolateral spine, MagnetOs MIS may be used standalone or with autograft as a bone extender. When used in intervertebral body fusion procedures, MagnetOs MIS must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. MagnetOs MIS resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K243474
Methodology: https://510kreport.com/methodology