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The Signature™ ONE System is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not precluded from being radiologically scanned. The Signature™ ONE System is designed for use on a skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the Signature™ ONE System. The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications: Zimmer® Trabecular Metal Reverse Plus® Shoulder. Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Comprehensive® Reverse Augmented Baseplates and Alliance® Glenoid System. The Signature™ ONE System pre-operative planning is also compatible with the humeral components of the following shoulder implant systems in accordance with their indications: Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, and Identity™ Shoulder System. The Signature™ ONE System Guides and bone models are intended for single use only.

The Signature™ ONE System is developed to assist in preoperative planning (using the Signature™ ONE Planner) and to accurately transfer a pre-operative plan to orthopedic surgical procedures (using the Signature™ ONE Guides and bone model) if desired in skeletally mature individuals for Total Shoulder Arthroplasty. Both anatomic and reverse (TSA and RSA respectively) approaches are supported. The Signature ONE Guides and Bone Models are designed and manufactured of polyamide (nylon) using additive manufacturing selective laser sintering (SLS), based on the approved/finalized pre-surgical plan and shipped prior to surgery. The guides and bone models are provided nonsterile and sterilized at the hospital. They are used intraoperatively to assist the surgeon in reproducing the plan on the scapula. The Signature ONE System surgical technique remains close to the conventional shoulder arthroplasty workflow. The Signature™ ONE System uses a Non-Device Medical Device Data System (MDDS) called the Zimmer Biomet Portal for the interaction with external users (i.e. imaging technician and the surgeon). The internal users (i.e. the Zimmer Biomet operators) use manufacturing software applications to prepare the patient cases for the surgeon. The purpose of this submission is to introduce new hardware kits for the existing compatible Comprehensive Reverse Augment implants and to include the addition of pre-operative planning of humeral components. A Rotational Guide component will be available as part of these two kits. Modifications have been made to the software applications to accommodate the new guide ordering option. The overall manufacturing process, materials, sterilization methods, have not changed from the previous primary predicate and principal of operation remains similar.