# K213418: MONTAGE Settable, Resorbable Hemostatic Bone Putty

- Pathway: 510(k) (Traditional)
- Applicant: Orthocon, Inc.
- Decided: Aug 30, 2023 after 679 days
- Product code: MTJ (Wax, Bone)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K791495 (1979). 27 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152005: MONTAGE Settable, Resorbable Hemostatic Bone Putty, Orthocon, Inc. (2015) Summary page 4.
- K111575: Hemasorb Absorbable Bone Hemostat Matrix, Orthocon, Inc. (2012) Summary page 4.

## Most influential descendants
- K242050: Montage Settable Bone Putty (2024), 1 descendant of its own
- K232998: Montage- XT Settable, Resorbable Hemostatic Bone Putty (2023), 1 descendant of its own
- K243506: Montage-XT Settable Bone Putty (2024), 0 descendants of its own

## Indications for use
MONTAGE Settable, Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries. MONTAGE is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.

Source page: https://510kreport.com/device/K213418
Methodology: https://510kreport.com/methodology