Orthocon, Inc. · Class II · Cleared Mar 13, 2026
| K-number | K253732 |
| Device name | Permatage Flowable, Settable Bone Paste |
| Applicant | Orthocon, Inc. |
| Product code | GXP |
| Device class | Class II |
| Decision date | Mar 13, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 882.5300 |
Permatage Flowable, Settable Bone Paste is a sterile, nonabsorbable material composed of two paste-like components containing granular calcium phosphate, paraffin oil, vitamin E acetate, triglyceride, and polyether-based polymers. When mixed, it forms a cohesive paste that adheres to bone and hardens, indicated for repair of neurosurgical burr holes, craniotomy cuts, and other cranial defects in skeletally mature individuals.
The device differs from its putty-form predicate in consistency (flowable paste versus putty), packaging (dual-barrel cartridge versus two foil packages), application method (manually operated dispenser versus manual application), and mixing time (immediate versus 45 seconds). Both contain identical biocompatible materials, are nonabsorbable, radiopaque, sterile by gamma irradiation, provide 2-minute working time, and set within 10 minutes with no exothermic reaction.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov