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The Titan Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The Titan Reverse Shoulder System is indicated for primary, fractures-including proximal humeral, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The glenoid base plate is intended for cementless application with the addition of screws for fixation. The humeral stem is indicated for cemented or uncemented use and the humeral body component is intended for cementless use.

The Integra TITAN Reverse Shoulder System is a semi-constrained modular total shoulder construct. The humeral components consist of humeral stems, varying heights of reverse bodies, and humeral poly liners. The poly liners are available in varying thicknesses and constraints to achieve stability and offset of the glenohumeral joint. The variable length reverse bodies and proximally-filling shape are designed to accommodate the natural humeral geometry, providing stable fixation as well as proximal bone loading. The glenoid components are composed of a baseplate secured by a central compression screw and 4 peripheral screws, two of which can be locked. A glenosphere is attached to the baseplate via taper lock. Glenospheres are available in varying offsets and lateralizations.

This document is a 510(k) premarket notification for the Integra® TITAN™ Reverse Shoulder System, specifically for an expanded indication to include fractures. It does not contain acceptance criteria or a study proving the device meets said criteria for an AI/CADe device.

The document states: "No additional verification and validation test data were required as part of this submission. This 510(k) was submitted to expand the current INTEGRA® TITAN™ Reverse Shoulder System to include fracture indications."

Therefore, I cannot provide the requested information for an AI/CADe device performance study from this document. The information focuses on demonstrating substantial equivalence to a predicate device for a change in labeling (adding a fracture indication) for a conventional medical implant.

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