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Indications For Use:

The Comprehensive Segmental Revision System is intended for use in cases of:

• 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Rheumatoid arthritis.
• 3. Revision where other devices or treatments have failed.
• 4. Correction of functional deformity.
• 5. Oncology applications including bone loss due to tumor resection.

When used in a proximal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for: Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.

When used as a distal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for: Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.

Biomet Comprehensive Segmental Revision System is indicated for use in a reverse application in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary. Reverse application is limited to proximal humeral replacement in the United States.

The Comprehensive Segmental Revision System is intended for use with or without bone cement in the proximal shoulder.

The Comprehensive Segmental Revision System is intended for use with bone cement in distal humeral applications.

Tissue Attachment Augments provide the option for tissue stabilization and attachment.

The Comprehensive Segmental Revision System (SRS) is a multi-piece orthopedic implant designed to replace the shoulder joint. The device is designed specifically for use in cases where there is extensive bone loss requiring extramedullay replacement of bone. The components of the Comprehensive SRS system have previously been cleared for use in hemi and anatomic total shoulder replacement. The current submission is to expand the indications to include reverse shoulder applications. All components have been previously cleared.

I am sorry, but based on the provided text, I cannot provide the detailed information you requested about acceptance criteria and the study proving the device meets them.

The document is a 510(k) premarket notification letter from the FDA to Biomet Manufacturing Corp. It determines substantial equivalence for the Comprehensive Segmental Revision System (SRS) to legally marketed predicate devices.

Here's why I cannot fulfill your request based on this document:

• No specific acceptance criteria or performance metrics are listed for the device itself. The document only details the "Indications for Use" for the device, which are the medical conditions or purposes for which it is intended.
• The document states "No new testing provided" under "Non-Clinical Tests" and "None provided" under "Clinical Tests" for the current submission (K173411). This means the FDA's substantial equivalence determination for this specific submission was based on existing data from previous clearances (K111746) and comparison to the predicate device, not on new studies conducted for this K173411.
• The details about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment for either training or test sets are not present in this regulatory letter. These types of details would typically be found in the comprehensive testing reports that accompany a 510(k) submission, not in the FDA's determination letter itself.

In summary, the provided text confirms the FDA's decision regarding substantial equivalence but does not contain the specific performance data, acceptance criteria, or study details you are asking for.

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