| K-number | K251296 |
| Device name | The Acumed Wrist Fixation System |
| Applicant | Acumed, LLC |
| Product code | HRS |
| Device class | Class II |
| Decision date | Jun 18, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The Acumed Wrist Fixation System is a metallic bone fixation appliance designed to provide fixation of fractures, fusions, osteotomies, and nonunions of the distal radius and ulna. It is indicated for prescription use in orthopedic surgical procedures to stabilize wrist injuries and pathological conditions requiring bone fixation.
Not stated in this summary.
Not stated in this summary.
The FDA determined the device is substantially equivalent to legally marketed predicate devices that predate the 1976 Medical Device Amendments, or to devices reclassified under the Federal Food, Drug, and Cosmetic Act. The device meets the regulatory definition for Class II metallic bone fixation appliances under 21 CFR 888.3030 and does not require a premarket approval application, allowing it to be marketed subject only to general controls provisions including registration, labeling, good manufacturing practice, and quality system regulations.
View the full FDA submission: accessdata.fda.gov