# K241027: Permatage Settable Bone Putty

- Pathway: 510(k) (Traditional)
- Applicant: Orthocon, Inc.
- Decided: Sep 26, 2024 after 164 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.
2 later devices descend from it; 2 cite it directly.
0 of 22 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.

## Most influential descendants
- K261265: Permatage XT Settable Bone Putty (2026), 0 descendants of its own
- K253732: Permatage Flowable, Settable Bone Paste (2026), 0 descendants of its own

## Indications for use
Orthocon Permatage 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 Settable Bone Putty should be used only in skeletally mature individuals.

Source page: https://510kreport.com/device/K241027
Methodology: https://510kreport.com/methodology