Search Results

The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including:

• Comminuted fractures .
• Supracondylar fractures .
• . Intra-articular and extra-articular condylar fractures
• Fractures in osteopenic bone .
• Nonunions e
• Malunions t

The Zimmer Periarticular Locking Plate System is a plate and screw system intended for internal fracture fixation. The low-profile periarticular locking plate is anatomically contoured and has threaded holes which accept locking screws to create a stable, fixed angle construct.

This is a 510(k) premarket notification for a medical device (Zimmer Periarticular Locking Plates), not an AI/ML device. Therefore, the typical acceptance criteria and study designs relevant to AI/ML device performance (like those involving test sets, ground truth, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable or detailed in this document.

The document states:

• Performance Data: "The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective."
• Comparison to Predicate Device: "The Zimmer Periarticular Locking Plate System has the same intended use, has similar performance characteristics, is manufactured from similar materials using similar processes, and is similar in design to the predicate devices."

This indicates that the acceptance criteria for this device are based on demonstrating substantial equivalence to a previously cleared predicate device through non-clinical (laboratory) performance testing, which typically includes mechanical and material testing to ensure safety and effectiveness for its stated intended use.

Since this is not an AI/ML device, the specific information requested in the prompt regarding AI/ML device performance evaluation (e.g., sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) is not present in the provided text.

Ask a specific question about this device