Medacta Anatomic Shoulder Prosthesis

• • Terminated Z-0775-2020 FDA Class II ·initiated 4 Nov 2019

  Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the humeral diaphysis.

510(k) Number

K170910 ↗

FDA Product Code

KWS

Device Class

Class II

Regulation

21 CFR Part 888.3660

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Medacta International S.A. →

• What types of shoulder procedures is this prosthesis designed for, and how does its modularity benefit patients?

  The Medacta Anatomic Shoulder Prosthesis is specifically designed for primary or revision total shoulder arthroplasty procedures, addressing degenerative or traumatic joint damage. Its modularity—including adjustable humeral inclination options (128°, 135°, and 142°)—allows surgeons to customize the implant to better match the patient’s unique shoulder anatomy, potentially improving fit, stability, and functional outcomes.

• Is this device intended for reuse, or is it strictly single-use? If reusable components exist, how are they handled?

  The Medacta Anatomic Shoulder Prosthesis is supplied sterile and intended for single-use. However, the system includes reusable components as part of its modular design, which can be sterilized and reused across multiple procedures. These reusable parts are likely designed for durability and compatibility with standard sterilization protocols, ensuring they remain safe for repeated use.

• Can this prosthesis be used in patients who require MRI scans after implantation, and why is this important?

  Yes, the Medacta Anatomic Shoulder Prosthesis is designed for compatibility with MRI environments, as specified by the manufacturer. This is particularly important for patients who may need follow-up imaging, as traditional shoulder prostheses can interfere with MRI scans, limiting diagnostic options. Compatibility with MRI reduces the risk of complications from imaging-related restrictions.

• What should clinicians consider when selecting the appropriate humeral inclination angle for a patient?

  Clinicians should select the humeral inclination angle based on the patient’s specific anatomy and the intended functional outcome. The Medacta system offers three anatomic configurations (128°, 135°, and 142°), which correspond to different shoulder anatomies. The choice depends on factors like bone structure, joint alignment, and the patient’s activity level, as these angles influence stability, range of motion, and long-term wear.

• How is the sterility of this device ensured, and what storage instructions should be followed?

  The Medacta Anatomic Shoulder Prosthesis is supplied sterile, meaning it undergoes terminal sterilization (likely via gamma irradiation or ethylene oxide) before packaging. To maintain sterility, clinicians should follow the manufacturer’s storage instructions, which typically include keeping the device in its sealed, sterile packaging until immediately before use, away from direct sunlight, extreme temperatures, and contamination sources. Reusable components must also be sterilized per validated protocols before reuse.