# K232771: Montage Flowable Settable, Resorbable Bone Paste

- Pathway: 510(k) (Traditional)
- Applicant: Orthocon, Inc.
- Decided: Feb 16, 2024 after 158 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: 9 generations back to K873689 (1987). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060763: Stryker Injectable Cement, Stryker (2006) Summary page 5.

## Indications for use
Orthocon Montage Flowable Settable, Resorbable Bone Paste 1s 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 25cm2. Montage Flowable Settable, Resorbable Bone Paste should be used only in skeletally mature mdividuals.

Source page: https://510kreport.com/device/K232771
Methodology: https://510kreport.com/methodology