# K233566: Montage-XT Settable, Resorbable Bone Putty

- Pathway: 510(k) (Traditional)
- Applicant: Orthocon, Inc.
- Decided: Aug 21, 2024 after 289 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: 11 generations back to K013966 (2002). 46 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 48 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 5.

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

## Indications for use
Orthocon Montage-XT Settable, Resorbable Bone Putty is indicated to fill bony voids or gaps in the skeletal system (i.e., extremities and pelvis). These defects may be surgically created, or osseous defects created as the result of traumatic injury to the bone. Montage-XT is indicated only for filling bony voids or gaps that are not intrinsic to the integrity of the bony structure. When hardened in situ, Montage-XT may be used to augment provisional hardware (e.g., k-wires, plates and screws) and to help support bone fragments during the surgical procedure. The hardened putty acts only as a temporary support medium and is not intended to provide structural support during the healing process. Montage-XT can be drilled and tapped, and hardware can be placed through it at any time during the setting process.

Source page: https://510kreport.com/device/K233566
Methodology: https://510kreport.com/methodology