# K261265: Permatage XT Settable Bone Putty

- Pathway: 510(k) (Special)
- Applicant: Orthocon, Inc.
- Decided: Jun 15, 2026 after 60 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
Permatage XT Settable Bone Putty is a self-setting cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects. Permatage XT Settable Bone Putty should be used only in skeletally mature individuals.

Source page: https://510kreport.com/device/K261265
Methodology: https://510kreport.com/methodology