| K-number | K253854 |
| Device name | MONTAGE XT Cranial Cement |
| Applicant | Orthocon, Inc. |
| Product code | GXP |
| Device class | Class II |
| Decision date | Jan 2, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 882.5300 |
MONTAGE XT Cranial Cement is a sterile, resorbable calcium phosphate cement comprised of two putty components that are mixed immediately before use. It is indicated for repair of neurosurgical burr holes, craniotomy cuts, and other cranial defects with a surface area no larger than 25 cm² in skeletally mature individuals.
The device is formulated as a two-part putty that forms a settable material when manually mixed. It contains granular calcium phosphate, calcium stearate, vitamin E acetate, triglyceride, polyalcohols, and lactide-diester and polyester-based polymers. Key difference from predicate: MONTAGE XT provides 4 minutes working time compared to 2 minutes for the predicate Montage Settable, Resorbable Bone Putty.
ISO 10993 biocompatibility testing was conducted, including cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, local tissue toxicity, hemolysis, pyrogenicity, and neurotoxicity studies under good laboratory practice (GLP) requirements.
MONTAGE XT is substantially equivalent to the predicate Montage Settable, Resorbable Bone Putty (K221933) because it has identical indications for use, same material composition, same putty-putty formulation that sets when mixed, same resorption mechanism, and same sterilization method. Previous biocompatibility and in vivo testing on related devices support safety and performance without requiring additional clinical studies.
View the full FDA submission: accessdata.fda.gov