Implantcast GmbH - FDA 510(k) Cleared Devices

Implantcast GmbH, is an innovative medical device manufacturer specializing in orthopedic implants. Based in Buxtehude, Germany, the company develops and produces primary, revision, and tumor endoprostheses for hip, knee, shoulder, and ankle applications. Since 1988, implantcast has grown to over 800 employees and serves a global distribution network across more than 64 countries.

The company has received 19 FDA 510(k) clearances from 19 total submissions, with all submissions focused on orthopedic devices. Clearances span from 2017 to 2026, demonstrating sustained regulatory activity and market presence. Recent cleared devices include the EPORE® XO cup system, implaFit® short stems, AGILON® XO Shoulder Replacement System, and MUTARS® femoral stem variants.

Implantcast is recognized for advanced manufacturing capabilities, including additive manufacturing (3D printing) and computer-assisted surgical planning tools. The company offers both standard product lines and custom-made prostheses tailored to individual patient anatomy. Notable product families include the MUTARS® tumor system, AGILON® shoulder systems, ACS® knee systems, and EcoFit® hip systems.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the 510(k) database.

510(k) submissions have been managed by Mcra, LLC as regulatory consultant.