FH Industrie · Class II · Cleared Aug 28, 2025
| K-number | K252411 |
| Device name | JARVIS Glenoid Reverse Shoulder Prosthesis |
| Applicant | FH Industrie |
| Product code | PHX |
| Device class | Class II |
| Decision date | Aug 28, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3660 |
The JARVIS Glenoid Reverse Shoulder Prosthesis is a reverse shoulder replacement implant indicated for patients with severe shoulder arthropathy and grossly deficient rotator cuff, or failed prior shoulder replacement with rotator cuff deficiency. It comprises three components—glenophere (cobalt chromium), baseplate (titanium), and fixation screws (titanium)—all provided sterile via gamma irradiation.
The subject device modifications involve threading all holes of the baseplate and changing the locking screw threading design. Materials remain identical to the predicate: baseplate and screws are Ti6Al4V-ELI per ASTM F-136/ISO 5832-3, while the glenophere is wrought cobalt chromium molybdenum per ASTM F1537/ISO 5832-12. Indications for use, materials, and overall dimensions are identical to the predicate device.
Materials conform to ASTM F-136/ISO 5832-3 (titanium alloy) and ASTM F1537/ISO 5832-12 (cobalt chromium molybdenum alloy). The document references sterilization via gamma irradiation but does not cite specific sterilization standards.
The design modifications—threading baseplate holes and modifying locking screw threads—do not change the underlying technology or raise different safety and effectiveness questions compared to the predicate K242253. Engineering analysis demonstrated that the compressive force of the modified screws is equivalent to the predicate, ensuring equivalent locking capabilities, so all prior performance testing and validations remain applicable.
View the full FDA submission: accessdata.fda.gov