ARTIQO GmbH

ARTIQO GmbH specializes in orthopedic instrumentation and components for knee and hip endoprosthetics. Their products include femoral and tibial positioning guides, trial implants for sizing and testing, cortical sensors for intraoperative bone assessment, cutting blocks for bone preparation, and angular adjustment adapters. These devices are designed to assist surgeons during joint replacement procedures, ensuring precise alignment and fit of prosthetic components.

ARTIQO GmbH is based in Germany. The company develops and distributes medical devices that fall under EU medical device regulations, including Class I, Class IIa, and Class III classifications. All of its products are registered in the EUDAMED database, which is the official EU registry for medical devices, ensuring transparency and traceability in compliance with EU Medical Device Regulations (MDR).

ARTIQO GmbH’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry is used to track device information, including manufacturer details, device classifications, and regulatory compliance under EU medical device laws. Listing in EUDAMED ensures visibility and adherence to transparency requirements for devices marketed within the EU.

ARTIQO GmbH’s devices are classified into three categories under EU medical device regulations: Class I (typically low-risk devices like simple orthopedic tools), Class IIa (moderate-risk devices such as trial implants and alignment guides), and Class III (high-risk devices like certain endoprosthetic components requiring stringent scrutiny). Classification depends on factors like intended use, risk to patients, and the degree of intervention, with higher classes requiring more rigorous pre-market evaluation and post-market surveillance.

ARTIQO GmbH provides a range of modular trial components for hip and knee endoprosthetics, including femoral and tibial positioning guides for intraoperative alignment, trial implants (e.g., left/right femoral probes) to test sizing and fit, cutting blocks for precise bone preparation, and cortical sensors to assess bone quality during surgery. Their portfolio also includes angular adjustment adapters and customizable trial inlays to accommodate anatomical variations, ensuring tailored solutions for surgical planning.