Orthocon, Inc. · Class II · Cleared Dec 5, 2024
| K-number | K243526 |
| Device name | MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty |
| Applicant | Orthocon, Inc. |
| Product code | MQV |
| Device class | Class II |
| Decision date | Dec 5, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 888.3045 |
MONTAGE is a sterile, resorbable bone void filler composed of two putty-like components containing calcium phosphate, calcium stearate, vitamin E acetate, triglycerides, polyalcohols, and lactide-diester/polyester-based polymers. When mixed, the components form a cohesive material that hardens in place and is used to fill bony voids or gaps in skeletal bones of the extremities resulting from benign bone cysts, tumors, surgical creation, or traumatic injury. The hardened material acts only as temporary support and can be drilled, tapped, and have hardware placed through it.
Not stated in this summary.
Not stated in this summary.
The subject device is substantially equivalent because it is identical to its reference devices (previous MONTAGE clearances K222063, K231903, K231270, K233566) in materials, manufacturing process, sterilization, and packaging. The only change is an expanded indications for use statement to include benign bone cysts and tumors in pediatric patients ≥6 years old. The submission relies on all pre-clinical and clinical testing from previous 510(k) clearances, arguing that risks associated with the expanded indication have been addressed through risk assessment without requiring new verification testing.
View the full FDA submission: accessdata.fda.gov