Search Results

The Catalyst CSR Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. The Catalyst CSR Shoulder System is intended for use in patients with the following conditions where the humeral head, neck and glenoid vault are of sufficient bone stock and the rotator cuff is intact or reconstructable.

• Osteoarthritis
• Avascular Necrosis
• Rheumatoid Arthritis
• Post-traumatic Arthritis
• Correction of functional deformity

The Catalyst CSR humeral and glenoid implants are intended for cemented use.

The Catalyst CSR Press-Fit humeral implants are intended for uncemented or cemented use.

The Catalyst CSR Shoulder System is a bone preserving total shoulder prosthesis designed for use in patients where the humeral head, neck and glenoid vault are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed.

This submission adds augmented glenoid components to the CSR Shoulder System. The CSR Augmented Glenoids are nearly identical to the previously cleared CSR 3 Peg Glenoids, except that additional material has been added to the fixation surface creating a 10 degree posterior wedge. Like the previously cleared CSR 3 Peg glenoid components, the CSR Augments are manufactured from UHMWPE conforming to ASTM F648. Also like the previously cleared CSR 3 Peg Glenoid components, three sizes of augmented glenoid components are available. The bearing surface has a symmetrical, oval shaped profile allowing use of each component on either the right or the left side. The glenoid component is designed to allow insertion at an angle, in the same orientation as the surgeon's exposure, to reduce the forceful retraction and bone and soft tissue trauma usually required to insert standard glenoid components. Three backside pegs are engineered to provide implant fixation within the dense cortical and subchondral bone.

The CSR Augmented Glenoid components are compatible with previously cleared CSR Press-Fit humeral components.

This document describes a 510(k) premarket notification for the Catalyst OrthoScience CSR Shoulder System, specifically focusing on the addition of augmented glenoid components. This is a medical device submission, and as such, it does not involve the type of AI/ML device performance criteria, studies, or ground truth establishment typically requested in your prompt.

Therefore, many of the requested fields are not applicable to this document. The existing information pertains to the non-clinical testing performed to demonstrate the device's safety and effectiveness for its intended use, rather than a clinical study evaluating diagnostic accuracy or similar AI model performance.

Here's a breakdown based on the provided text, indicating where information is not applicable:

1. A table of acceptance criteria and the reported device performance

Ask a specific question about this device