# K241212: MagnetOs Easypack Putty

- Pathway: 510(k) (Traditional)
- Applicant: Kuros Biosciences
- Decided: Jun 27, 2024 after 58 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: 27 generations back to K841189 (1984). 418 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 420 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233490: SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty, Bioventus, LLC (2023) Summary page 5.
- K240442: MagnetOs Putty, Kuros Biosciences B.V (2024) Summary page 5.
- K233607: MagnetOs Easypack Putty, Kuros Biosciences B.V (2023) Summary page 5.
- K232347: MagnetOs Granules, Kuros Biosciences B.V (2024) Summary page 5.

## Most influential descendants
- K243474: MagnetOs MIS (2025), 0 descendants of its own

## Indications for use
MagnetOs Easypack Putty 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 Easypack Putty may be used standalone or with autograft as a bone extender. When used in intervertebral body fusion procedures, MagnetOs Easypack Putty must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. MagnetOs Easypack Putty resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K241212
Methodology: https://510kreport.com/methodology