Globus Medical, Inc. · Class II · Cleared Dec 6, 2024
| K-number | K241260 |
| Device name | ACTIFY Unicondylar Knee System |
| Applicant | Globus Medical, Inc. |
| Product code | HSX |
| Device class | Class II |
| Decision date | Dec 6, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 888.3520 |
The ACTIFY™ Unicondylar Knee System is a partial knee replacement implant for patients with single-compartment knee disease. It consists of a cobalt-chrome femoral component, a titanium alloy tibial tray, and an ultra-high molecular weight polyethylene (UHMWPE) insert, indicated for cemented implantation in conditions including osteoarthritis, post-traumatic arthritis, avascular necrosis, and varus/valgus deformities.
The ACTIFY implants have identical technological characteristics to predicate devices: the same design philosophy for unicompartmental knee replacement, identical material composition (cobalt-chrome femoral, titanium tibial tray, UHMWPE inserts with optional Vitamin E), equivalent function as a non-constrained cemented prosthesis, and the same range of sizes to accommodate patient anatomy variation.
Performance testing was conducted per ASTM F1223, ASTM F1814, ASTM F1877, ASTM F2083, ASTM F3140, ASTM F3210, ISO 14243-2, and ISO 14243-3, covering fatigue, wear, interlocking strength, constraint, range of motion, contact area, and contact stress.
The ACTIFY system is substantially equivalent because it shares the same design, materials, function, and intended use as the predicate devices (StelKast, Smith & Nephew ZUK, and Stryker Triathlon PKR systems). Performance testing demonstrates equivalent mechanical and wear characteristics across all critical parameters, and the device is indicated for identical clinical conditions via the same cemented surgical approach.
View the full FDA submission: accessdata.fda.gov