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Medacta Shoulder System - Reverse

Reverse Shoulder Prosthesis

The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly rotator cuff deficient shoulder joint, severe arthropathy failed joint replacement and a grossly rotator cuff deficient shoulder joint.

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application of screws for primary stability.

Short Humeral Diaphysis

The Reverse Shoulder Prosthesis- Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy.

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

Medacta Shoulder System - Anatomic

Anatomic Shoulder Prosthesis

The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application.

Short Humeral Diaphysis

The Medacta Anatomic Shoulder Prosthesis – Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application.

The Medacta Shoulder Systems are modular systems intended to be used for shoulder arthroplasty (anatomical or reverse). System components were previously cleared by the FDA under K170910 (anatomic shoulder prosthesis) and K170452 (reverse shoulder prosthesis).

The Long Humeral Diaphysis implants, subject of this 510(k), are implantable devices used to replace the humeral side of the gleno-humeral joint. The product is intended to be used with the Medacta Shoulder System components as an alternative to the Standard Humeral Diaphysis components provided with those systems.

The Medacta Shoulder System Long Humeral Diaphysis couples with the Humeral Reverse Metaphysis (K170452) in the reverse configuration and the cemented and cementless Humeral Anatomic Metaphysis (K170910) in the anatomic configuration. The long humeral diaphysis, provided in 160 mm and 200 mm length options, may be used when additional distal stability in the humeral canal is needed.

The subject devices are manufactured from titanium alloy (Ti6A17Nb) and are provided sterile in 11 sizes per length option.

This device is a medical implant, not an AI/ML device, therefore, the requested information regarding acceptance criteria and study details related to AI/ML performance is not applicable. The provided text is an FDA 510(k) clearance letter and summary for a physical medical device: the Medacta Shoulder System. This document focuses on demonstrating substantial equivalence to a predicate device through material, design, and performance testing, which are different from the criteria typically found in AI/ML device evaluations.

However, I can provide a summary of the performance data that was provided in support of the substantial equivalence determination for this medical device, as described in the document.

Performance Data Provided:

The 510(k) summary lists the following performance data:

• Sterilization Validation: Per UNI EN ISO 11137-1:2015 and AAMI/ANSI/ISO 11137-2:2013. This ensures the device can be properly sterilized for safe use.
• Fatigue Testing: Per ASTM F1378-17. This evaluates the device's mechanical durability and its ability to withstand repeated stress over time, simulating conditions within the human body.
• Cadaver Studies: These studies typically assess surgical technique, implant fit, and preliminary biomechanical performance within an anatomical context.

Please note that none of the specific AI/ML related questions (sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance) are relevant to the information presented in this 510(k) summary for the Medacta Shoulder System.

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