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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 g 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 wellfixed/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/REVISION (L), and FRACTURE (F) humeral components are as follows:
  | P | L | F | Indications |
  |---|---|---|---|
  | √ | √ | | Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic
  degenerative problems |
  | √ | √ | | Congenital abnormalities in the skeletally mature |
  | √ | | | Primary and secondary necrosis of the humeral head. |
  | √ | | √ | Humeral head fracture with displacement of the tuberosities |
  | √ | √ | | Pathologies where arthrodesis or resectional arthroplasty of the humeral
  head are not acceptable |
  | √ | √ | | Revisions of humeral prostheses when other treatments or devices have
  failed (where adequate fixation can be achieved) |
  | | | √ | Displaced three-part and four-part upper humeral fractures |
  | | √ | | Spiral and other fractures of the mid-humerus (in combination with
  glenohumeral degenerative diseases) |
  | | √ | | Revision of failed previous reconstructions when distal anchorage is
  required |
  | √ | √ | | To restore mobility from previous procedures (e.g. previous fusion) |
  | √ | √ | √ | Rotator cuff tear arthropathy |
  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 (hemiarthroplasty), 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 Equinoxe Superior/Posterior Augment Reverse Shoulder Glenoid Baseplates are modifications to augmented Equinoxe reverse shoulder glenoid baseplate devices cleared through premarket notification #K110708.
This submission proposes the following design changes:

• 1. The proposed device combines a 10° superior augment and an 8° posterior augment previously provided as separate options in the scope of the cited predicate devices
• 2. The cage peg length is increased to 21.5mm as compared to 17mm for the predicate 10° superior augment glenoid baseplate and 15.7mm for the predicate 8º posterior augment glenoid

This document is a marketing approval letter from the FDA for a medical device, the Exactech® Equinoxe® Reverse Shoulder System. It does not contain acceptance criteria or study results that prove the device meets acceptance criteria.

The letter acknowledges that the device is "substantially equivalent" to legally marketed predicate devices, which means it has the same intended use and technological characteristics as a device already on the market. This type of submission (510(k)) generally relies on demonstrating equivalence rather than providing new clinical data to prove safety and effectiveness.

The section titled "Non-Clinical Performance Data" mentions "Fixation assessment" and "Cyclic abduction loosening testing" but only provides the type of evaluation, not the acceptance criteria for these tests nor the results. Therefore, I cannot extract the requested information from this document.

To answer your request, I would need a different type of document that details the specific acceptance criteria for a device, the methodology of a study designed to meet those criteria, and the reported performance results of that study. This document only confirms the device's substantial equivalence to a previous version and lists its indications for use.

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