| K-number | K250760 |
| Device name | SPECTRUM GV Bone Cement |
| Applicant | Osteoremedies, LLC |
| Product code | LOD |
| Device class | Class II |
| Decision date | Apr 2, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3027 |
SPECTRUM® GV Bone Cement is a radiopaque polymethylmethacrylate (PMMA) bone cement containing gentamicin and vancomycin. It is a single-use, sterile device with liquid and powder components mixed immediately before use, intended for fixation of REMEDY® spacers and prostheses to living bone during the second stage of two-stage revision total joint arthroplasty after infection clearance.
The technological characteristics of the subject device are unchanged versus the predicate SPECTRUM® GV Bone Cement (K231556). The device remains a traditional PMMA bone cement with identical composition, materials, design, and function.
Not stated in this summary.
The subject SPECTRUM® GV Bone Cement is identical to the predicate device K231556 in materials, design, and function. The only difference is a minor clarification in the indications for use to specify the device may be used in total joint arthroplasty as part of two-stage revision when initial infection has been cleared. Since no technological changes exist and the intended use remains substantially the same, no new non-clinical testing was required.
View the full FDA submission: accessdata.fda.gov