# K253854: MONTAGE XT Cranial Cement

- Pathway: 510(k) (Special)
- Applicant: Orthocon, Inc.
- Decided: Jan 2, 2026 after 30 days
- Product code: GXP (Methyl Methacrylate For Cranioplasty)
- Device class: 2
- Regulation: 21 CFR 882.5300
- 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 K873689 (1987). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221933: MONTAGE Settable, Resorbable Bone Putty, Orthocon, Inc. (2023) Summary page 5.

## Indications for use
MONTAGE XT Cranial Cement is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts, and other cranial defects with a surface area no larger than 25 cm2. MONTAGE XT Cranial Cement should be used only in skeletally mature individuals.

Source page: https://510kreport.com/device/K253854
Methodology: https://510kreport.com/methodology