# K243506: Montage-XT Settable Bone Putty

- Pathway: 510(k) (Special)
- Applicant: Orthocon, Inc.
- Decided: Nov 18, 2024 after 6 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: 14 generations back to K791495 (1979). 77 ancestors in all.
No later device cites it as a predicate yet.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242050: Montage Settable Bone Putty, Orthocon, Inc. (2024) Summary page 6.
- K233566: Montage-XT Settable, Resorbable Bone Putty, Orthocon, Inc. (2024) Summary page 6.
- K232998: Montage- XT Settable, Resorbable Hemostatic Bone Putty, Orthocon, Inc. (2023) Summary page 6.
- K220315: MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty, Orthocon, Inc. (2022) Summary page 6.

## Indications for use
Montage-XT Settable Bone Putty is indicated for use on the sternum in cardiothoracic surgery following sternotomy to control bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade, as well as to fill bony voids or gaps in the sternum. When hardened in situ, Montage-XT may be used on the sternum to augment hardware to help support bone during the cardiothoracic surgical procedure.

Source page: https://510kreport.com/device/K243506
Methodology: https://510kreport.com/methodology