Zimmer Biomet · Class II · Cleared Jul 25, 2025
| K-number | K251620 |
| Device name | A.L.P.S. Proximal Humerus Plating System |
| Applicant | Zimmer Biomet |
| Product code | HRS |
| Device class | Class II |
| Decision date | Jul 25, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The A.L.P.S. Proximal Humerus Plating System is a titanium alloy bone fixation device used to treat fractures, dislocations, fusions, osteotomies, and non-unions of the humerus, particularly in osteopenic bone. The system includes locking and non-locking screws, multidirectional screws, and general orthopedic instrumentation, available in gamma-sterilized or non-sterile configurations for left and right sides in various lengths.
The A.L.P.S. Proximal Humerus Plating System shares the same fundamental scientific technology as the predicate device, with similar intended use, basic shape, material (titanium alloy), and performance characteristics. There is no change in the fundamental scientific technology between the subject and predicate devices, and the technological characteristics do not raise new questions of safety and effectiveness.
Not stated in this summary.
The device is substantially equivalent because it has identical intended use (fixation of proximal humerus fractures and related conditions) and similar technological characteristics to the predicate Biomet Proximal Humerus Plating System. Non-clinical testing including implant construct axial load static and fatigue testing, plus screw and peg performance testing, demonstrated that any differences do not raise different safety and effectiveness questions. The proposed device is at least as safe and effective as the legally marketed predicate device.
View the full FDA submission: accessdata.fda.gov