# K242050: Montage Settable Bone Putty

- Pathway: 510(k) (Special)
- Applicant: Orthocon, Inc.
- Decided: Jul 29, 2024 after 17 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: 13 generations back to K791495 (1979). 73 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222063: MONTAGE Settable, Resorbable Bone Putty, Orthocon, Inc. (2023) Summary page 6.
- K213418: MONTAGE Settable, Resorbable Hemostatic Bone Putty, Orthocon, Inc. (2023) Summary page 6.
- K152005: MONTAGE Settable, Resorbable Hemostatic Bone Putty, Orthocon, Inc. (2015) Summary page 6.
- K141502: HBP4 Hardening, Resorbable Hemostatic Bone Putty, Orthocon, Inc. (2014) Summary page 6.

## Most influential descendants
- K243506: Montage-XT Settable Bone Putty (2024), 0 descendants of its own

## Indications for use
Montage 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 may be used on the sternum to augment hardware to help support bone during the cardiothoracic surgical procedure.

Source page: https://510kreport.com/device/K242050
Methodology: https://510kreport.com/methodology