Baumer, S.A

Baumer, S.A specializes in orthopedic implants. Their product line includes femoral heads, hip prostheses (such as the Baumer Muller Hip Prosthesis and Baumer Cemented Hip Prosthesis), and locking nails for hip and femoral fixation. These devices are designed to support surgical procedures related to joint replacement and bone stabilization.

Baumer, S.A is based in the United States. Since the company operates within the U.S., its orthopedic implants are subject to FDA regulations. The FDA classifies these devices as Class II, which requires premarket notification (510(k)) submissions to demonstrate substantial equivalence to legally marketed predicate devices before commercial distribution.

Baumer, S.A’s orthopedic implants are listed in the FDA’s 510(k) registry. This pathway confirms that the devices have undergone the required premarket notification process to demonstrate compliance with FDA regulations before being marketed in the U.S. The registry serves as a public record of these submissions.

Baumer, S.A’s devices—such as femoral heads, hip prostheses, and locking nails—are classified as Class II under FDA regulations. This classification applies to devices that pose moderate risk and require special controls (like design reviews or performance standards) to ensure safety and effectiveness. The 510(k) pathway is used to demonstrate that these devices meet those controls.