Prosidyan, Inc. · Class II · Cleared Jun 24, 2025
| K-number | K251648 |
| Device name | GPS Advanced; GPS Advanced Cannula |
| Applicant | Prosidyan, Inc. |
| Product code | FMF |
| Device class | Class II |
| Decision date | Jun 24, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 880.5860 |
GPS Advanced and GPS Advanced Cannula are sterile, single-use dispensers designed to deliver FIBERGRAFT™ BG Putty GPS, a bioactive synthetic bone graft substitute, to bone grafting sites. The GPS Advanced features a ratcheted plunger mechanism that advances with each squeeze of the handle, while the 5 cc GPS Advanced Cannula is an individually packaged attachment that is filled with the bone graft material prior to use.
The technological characteristics of GPS Advanced and GPS Advanced Cannula are consistent with those of the predicate devices in terms of design, materials, principle of operation, and performance. GPS Advanced is sterilized via irradiation while GPS Advanced Cannula is sterilized via ethylene oxide.
Not stated in this summary.
The devices are substantially equivalent because their indications for use (delivering FIBERGRAFT™ BG Putty GPS to a bone grafting site) are identical to the predicate device, and their technological characteristics including design, materials, and principle of operation are consistent with those of the primary predicate (K241426) and reference predicate (K201338). The performance data—biological risk assessment, sterilization validation, and packaging/shelf-life testing—support that the devices function equivalently to their predicates.
View the full FDA submission: accessdata.fda.gov