Search Results

The Equinoxe Shoulder System is in skeletally manre individuals with degeneralive diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.

• The cemented primary humeral stem, long/revision stems and all Equinoxe glenoids are ● intended for cemented fixation.
• The press-fit humeral stems are intended for press-fit applications but may be 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 well-fixed/stable, as deemed by the orthopaedic surgeon.
• Humeral Heads are intended for use in cemented and press-fit applications. .

Clinical indications for the PRIMARY (I'), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows:

The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degeneralive 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 foss 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 humens and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemi-arthroplasty), 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 ceniented use only.

The modifications proposed by this submission describe minor geometry changes to the standard offering of Equinoxe glenospheres, glenoid plates, and compression screws; these geometry modifications are the entire basis for proposed Reverse Shoulder line extensions (expanded offset glenospheres, posterior and superior augmented glenoid plates, +10mm extended cage glenoid plate, and longer compression screws).

All proposed components are designed to interface and articulate with the Equinoxe Shoulder system and are supplied sterile.

The provided document describes a 510(k) premarket notification for the Exactech® Equinoxe® Reverse Shoulder™ Line Extensions. This document focuses on the substantial equivalence of the device to legally marketed predicate devices, not on a study to determine device performance against specific clinical acceptance criteria in terms of accuracy or efficacy in diagnosing conditions.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, and ground truth establishment, cannot be extracted from this document as it is not relevant to the type of submission provided.

The document primarily addresses the following for the "Exactech® Equinoxe® Reverse Shoulder™ Line Extensions":

• Intended Use: Total Shoulder Arthroplasty.
• Materials: Equivalent to predicate devices, conforming to industry standards.
• Dimensions: Available in equivalent size ranges to predicate devices.
• Sterilization Processes: Sterile for single use, conforming to industry standards.
• Performance Specifications: Withstand clinically relevant biomechanical loads.

Substantial Equivalence Conclusion: Based on mechanical tests, simulated-use tests, engineering analyses, and a clinical literature summary, the proposed device is substantially equivalent to predicate devices.

The evidence for this conclusion includes:

• Cadaver lab validation to demonstrate design features.
• Geometric computer analysis to evaluate the relationship between design parameters and Range of Motion (ROM), impingement, and stability.
• Dynamic test at worst-case physiological load in a polyurethane bone substitute to evaluate initial fixation, loosening, and disassociation.
• Clinical literature summary related to cuff tear arthroplasty and reverse shoulder arthroplasty.

Ask a specific question about this device