Refobacin Bone Cement R (110034355)
Device Facts
| Record ID | K254107 |
|---|---|
| Device Name | Refobacin Bone Cement R (110034355) |
| Applicant | Biomet France |
| Product Code | LOD · Orthopedic |
| Decision Date | Apr 15, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3027 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
