Orthocon, Inc. · Class II · Cleared Mar 16, 2026
| K-number | K253447 |
| Device name | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) |
| Applicant | Orthocon, Inc. |
| Product code | GXR |
| Device class | Class II |
| Decision date | Mar 16, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 882.5250 |
Montage Flowable Settable, Resorbable Bone Paste is a self-setting cement for fixation of bone flaps following craniotomy in skeletally mature individuals. It comprises two separate paste-like components containing calcium phosphate, calcium stearate, vitamin E acetate, triglycerides, polyalcohols, and polymers that mix together and harden to mechanically secure cranial bone flaps in place.
The device is formulated as a two-part flowable paste that forms a settable calcium phosphate-based material when mixed, with resorption occurring in greater than 30 days due to calcium phosphate presence. It is provided in a dual-barrel cartridge with sterile barrier packaging and is available in volumes up to 8cc, delivered via manual dispenser to the cranial defect.
Testing was conducted per ISO 10993 biocompatibility recommendations including cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, local tissue toxicity, hemolysis, pyrogenicity, and neurotoxicity. Performance testing followed recognized standards and protocols as stated in the submission.
Substantial equivalence is established through comparison with the OSSDSIGN Cranioplug predicate (K181539): both devices provide mechanical fixation of cranial bone, contain calcium phosphate components, are resorbable, demonstrate equivalent mechanical stability and fixation means, use similar sterile packaging, and have undergone comparable biocompatibility and performance testing demonstrating safety and suitability.
View the full FDA submission: accessdata.fda.gov