Acumed, LLC - FDA 510(k) Cleared Devices

Acumed, LLC is a privately owned medical device manufacturer based in Hillsboro, Oregon. Founded in 1988, the company designs, manufactures, and markets orthopedic implants and surgical devices for global markets.

Acumed has received 38 FDA 510(k) clearances from 38 total submissions since 2003. The company specializes exclusively in Orthopedic devices, with a regulatory track record spanning over two decades. The latest clearance in 2025 reflects continued active development and market engagement.

The company's cleared device portfolio includes wrist fixation systems, ankle syndesmosis repair systems, clavicle hook plating systems, and headless compression screw systems. These products represent core surgical tools for fracture fixation and orthopedic reconstruction across multiple anatomical sites.

Now part of Colson Associates, a Berkshire Hathaway subsidiary, Acumed continues to operate as an active orthopedic device manufacturer with nearly 500 employees domestically and internationally. Explore the complete list of device names, product codes, and clearance dates in the database.