Medacta Shoulder System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K170452 ↗

FDA Product Code

PHX

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 surgical procedures is the Medacta Shoulder System designed for?

  The Medacta Shoulder System is specifically engineered for shoulder arthroplasty procedures, including total shoulder arthroplasty (TSA) and reverse shoulder arthroplasty (RSA). Its modular design allows for anatomical and reverse configurations, accommodating a range of patient anatomies through adjustable offset and multiple humeral inclination angles (128°, 135°, 142° for TSA; 145°, 155° for RSA). This flexibility ensures tailored solutions for different surgical needs.

• How is the Medacta Shoulder System supplied, and what does this mean for clinical use?

  The Medacta Shoulder System is supplied as a sterile, single-use device. This means each component is intended for one-time use in a single patient, reducing the risk of cross-contamination and ensuring sterility throughout the procedure. Clinicians should follow manufacturer guidelines for opening and handling to maintain sterility until implantation.

• What humeral inclination angles are available for total shoulder arthroplasty (TSA) and reverse shoulder arthroplasty (RSA)?

  For total shoulder arthroplasty (TSA), the system offers three humeral inclination angles: 128°, 135°, and 142°. For reverse shoulder arthroplasty (RSA), two angles are provided: 145° and 155°. These options allow surgeons to select the optimal angle based on the patient’s anatomy and surgical requirements, ensuring a more precise fit and restoration of function.

• Are there different stem options available in the Medacta Shoulder System, and why might this matter?

  Yes, the Medacta Shoulder System includes two stem options: a standard stem and a short stem. The choice between these depends on the patient’s bone structure and clinical needs. A standard stem may be suitable for patients with sufficient bone length, while the short stem can be beneficial for those with limited bone stock, reducing the risk of stress shielding or bone resorption.

• What regulatory pathway was followed for FDA clearance of the Medacta Shoulder System?

  The Medacta Shoulder System received FDA clearance through the 510(k) pathway, specifically under product code PHX. The submission was classified as substantially equivalent (SESE) and underwent a traditional review process with advisory committee classification under Orthopedic (OR). This pathway ensures the device meets FDA standards for safety and effectiveness compared to legally marketed predicate devices.