Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants

The Equinoxe Humeral Reconstruction Prosthesis is a shoulder replacement device designed to replace both the humeral head and resected humerus in hemi or total shoulder arthroplasty. The Equinoxe Stemless Shoulder System is an anatomic total shoulder prosthesis for degenerative glenohumeral joint disease. Both devices are manufactured from titanium alloy with titanium plasma spray and hydroxyapatite coatings and are available in multiple sizes and configurations.

The proposed and predicate devices are composed of the same biocompatible materials (Ti-6Al-4V with TPS and HA coating), have the same design features including modular construction with proximal bodies and distal stems, are provided sterile for single use only, and conform to recognized performance standards for shoulder replacement devices. The addition of MR conditional labeling distinguishes the proposed device from predicates.

Non-clinical testing was performed in accordance with ASTM F2503 for MR environment compatibility, including ASTM F2052 displacement testing, ASTM F2213 magnetically induced torque, ASTM F2119 MR image artifact, and ASTM F2182 RF-induced heating. No clinical testing was included in this submission.

The proposed device is substantially equivalent to its predicates because both the subject and predicate devices share identical intended use and scientific technology, are composed of the same biocompatible materials, have the same design features and performance characteristics, and the only material difference is the addition of MR conditional labeling based on non-clinical MR safety testing that supports substantial equivalence.