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The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemiarthroplasty is determined by the surgeon to be the preferred method of treatment.

• The cemented primary humeral stem, long/revision stem, fracture stems and all Equinoxe glenoids are intended for cemented fixation.
• The press-fit humeral stems are intended for press-fit applications but may be used with bone cement at the discretion the surgeon.
• The reverse humeral components are intended to be used in cemented applications or in revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
• Humeral Heads are intended for use in cemented and press-fit applications.

Clinical indications for the PRIMARY (P), LONG (L) and FRACTURE (F) humeral components are as follows:

The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

The Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.

The proposed Exactech Equinoxe CTA Humeral Head devices are humeral heads for use with the Equinoxe Shoulder System cleared via 510(k) K042021. Compared to predicate Equinoxe humeral heads, the proposed CTA Humeral Heads have an extended articular surface, designed to to contact the acromion in a rotator-cuff deficient patient.

This is not an AI/ML device. It is a medical device (humeral head for shoulder replacement) that underwent a 510(k) premarket notification process based on substantial equivalence to predicate devices, not on AI/ML performance.

Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not applicable to this document.

The document discusses:

• Intended Use & Indications for Use: Similar to predicate devices.
• Materials, Dimensions, Sterilization processes: Equivalent to predicate devices and conform to industry standards.
• Performance specifications: Conform to recognized performance standards for total shoulder joint replacement.

The "Substantial Equivalence Conclusion" is based on:

• Cadaver and sawbones lab validation
• Mechanical testing to verify structural integrity and fixation properties
• Clinical literature reviews of CTA devices and clinical failure modes

This information does not relate to an AI/ML device's performance characteristics.

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