Heraeus Medical LLC

Heraeus Medical LLC specializes in orthopaedic devices, primarily focusing on bone cements and related products. Their portfolio includes non-antimicrobial and antimicrobial orthopaedic cements, bone matrix implants made from synthetic materials, orthopaedic cement spacers, and moulds for knee and hip revision trials. They also produce orthopaedic cement dispensers for surgical use. Examples of their products include PALACOS®, COPAL® knee mould Trial L US, Synthecure, and OSTEOPAL®.

Heraeus Medical LLC is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites may vary.

Heraeus Medical LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices authorised for use in the United States, including classification under FDA categories.

Heraeus Medical LLC’s devices are classified under the FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional regulations due to moderate risk. Classification depends on factors like the device’s intended use, potential harm, and clinical data.

Heraeus Medical LLC offers both antimicrobial and non-antimicrobial orthopaedic cements to address different clinical needs. Antimicrobial variants contain additives designed to inhibit bacterial growth, reducing infection risks during orthopaedic procedures like joint revisions. Non-antimicrobial cements lack these additives and are used where infection risk is lower or additional properties (e.g., mechanical strength) are prioritised.