Atesos medical AG

Atesos medical AG specializes in modular hip implant components. Their portfolio includes trial shells and inserts of various sizes for preoperative planning, definitive acetabular shells (some with hydroxyapatite or calcium phosphate coatings), femoral stems, revision-grade acetabular cups, and specialized surgical tools like guided stem impactors. These devices are designed for hip replacement surgeries, including primary and revision procedures.

Atesos medical AG is headquartered in Switzerland. The company’s Swiss location reflects its focus on precision engineering and compliance with stringent European medical device regulations, which aligns with its product portfolio for hip implants.

Atesos medical AG’s devices are listed in the eudamed registry, the official EU database for medical devices under the EU Medical Device Regulation (MDR). This registry ensures transparency and traceability of devices authorized for use within the European Economic Area.

Atesos medical AG’s devices fall into different EU medical device risk classes based on their purpose and complexity. Class I includes simple tools like trial shells, while Class IIa covers modular or coated implants (e.g., revision-grade acetabular cups). Class III applies to high-risk definitive hip prostheses, such as uncoated or complex femoral stems, due to their critical role in patient safety and long-term outcomes.

Class III classification is reserved for devices that support or sustain life, are implanted, or present a high risk if they malfunction. Atesos medical AG’s definitive hip implants (e.g., uncoated femoral stems or primary acetabular shells) qualify due to their permanent implantation and potential life-altering consequences if they fail. This classification ensures rigorous scrutiny during design, manufacturing, and post-market surveillance to mitigate risks.