# K253447: Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)

- Pathway: 510(k) (Traditional)
- Applicant: Orthocon, Inc.
- Decided: Mar 16, 2026 after 165 days
- Product code: GXR (Cover, Burr Hole)
- Device class: 2
- Regulation: 21 CFR 882.5250
- 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). 51 ancestors in all.
No later device cites it as a predicate yet.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181539: OSSDSIGN Cranioplug, Ossdsign AB (2018) Summary page 5.

## Indications for use
Orthocon Montage Flowable Settable, Resorbable Bone Paste is a self-setting cement indicated for fixation of bone flaps following craniotomy. Montage Flowable Settable, Resorbable Bone Paste should be used only in skeletally mature individuals.

Source page: https://510kreport.com/device/K253447
Methodology: https://510kreport.com/methodology