# K231386: Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste

- Pathway: 510(k) (Traditional)
- Applicant: Orthocon, Inc.
- Decided: Jul 11, 2023 after 60 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: 14 generations back to K791495 (1979). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193052: HBP6 Settable, Resorbable Hemostatic Bone Paste, Orthocon, Inc. (2020) Summary page 4.

## Indications for use
Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

Source page: https://510kreport.com/device/K231386
Methodology: https://510kreport.com/methodology