# K253732: Permatage Flowable, Settable Bone Paste

- Pathway: 510(k) (Traditional)
- Applicant: Orthocon, Inc.
- Decided: Mar 13, 2026 after 109 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)
- K241027: Permatage Settable Bone Putty, Orthocon, Inc. (2024) Summary page 5.

## Indications for use
Orthocon Permatage Flowable, Settable Bone Paste is a self-setting cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects. Permatage Flowable, Settable Bone Paste should be used only in skeletally mature individuals.

Source page: https://510kreport.com/device/K253732
Methodology: https://510kreport.com/methodology