# K222063: MONTAGE Settable, Resorbable Bone Putty

- Pathway: 510(k) (Traditional)
- Applicant: Orthocon, Inc.
- Decided: Feb 3, 2023 after 205 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: 10 generations back to K013966 (2002). 45 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161447: HydroSet XT, Orthovita, Inc. (2016) Summary page 4.

## Most influential descendants
- K233566: Montage-XT Settable, Resorbable Bone Putty (2024), 1 descendant of its own
- K242050: Montage Settable Bone Putty (2024), 1 descendant of its own
- K243506: Montage-XT Settable Bone Putty (2024), 0 descendants of its own

## Indications for use
Orthocon MONTAGE Settable, Resorbable Bone Putty is indicated to fill bony voids or gaps in the skeletal system (1.e. extremities and pelvis). These defects may be surgically created, or osseous defects created as the result of traumatic injury to the bone. MONTAGE is indicated only for filling bony voids or gaps that are not itrinsic to the integnity of the bony structure. When hardened in situ, MONTAGE 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 1s not intended to provide structural support during the healing process. MONTAGE can be dnlled and tapped. and hardware can be placed through it at any time duning the setting process.

Source page: https://510kreport.com/device/K222063
Methodology: https://510kreport.com/methodology