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The Aequalis Ascend Modular Anatomic Shoulder System is indicated for use as a replacement of Shoulder joints disabled by:

• Rheumatoid arthritis with pain
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis

Notes:

• All components are single use
• The humeral stem is intended for cemented or cementless use
• The glenoid component is intended for cemented use

The Aequalis Ascend Modular Anatomic Shoulder system is supplied in separate sterile packages which will be assembled in the operating room. The system is comprised of the following components:

• The Modular Distal Stem
• The Modular Anatomic Metaphysis
• The Modular Anatomic Assembly Screw.
  This assembly will mate with existing; FDA cleared Tornier Ascend Monolithic Humeral Heads (K071147) which were designed to articulate with FDA cleared Tornier Aequalis and Affiniti Glenoid replacements (K063081 and K060988 respectively).

This submission corresponds to a change made to the Aequalis Ascend Modular Anatomic Shoulder System (previously cleared in 510(k) K102924).

The provided text is for a 510(k) summary for a medical device called the "Aequalis Ascend Modular Anatomic Shoulder System." It focuses on demonstrating substantial equivalence to a predicate device through bench testing. Biomedical devices, unlike AI/ML devices, do not have the same set of acceptance criteria, study types, and ground truth definitions. The document does not contain information about the topics requested in the input.

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