Search Results

The APTUS® 2.0/2.3 Four Corner Fusion Plate, an addition to the APTUS® Titanium Fixation System, is designed specifically for fusion of carpal bones including: hamate, capitate, lunate, triquetrum and is for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with locking and non-locking screws that fix the plate to the carpal bones of the hand.

The APTUS® 2.0/2.3 Four Corner Fusion Plate consists of a titanium fixation plate designed specifically for fusion of carpal bones including: hamate, capitate, lunate, triquetrum. The fusion plate is used in conjunction with screws that fix the plate to the carpal bones of the hand.

The provided text is a 510(k) summary for the Medartis AG APTUS® 2.0/2.3 Four Corner Fusion Plate. This document describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria, specific studies (like clinical trials or performance studies), sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot populate the requested table and answer the questions based on the provided text. The document is a regulatory submission for premarket notification, which focuses on demonstrating substantial equivalence to existing devices rather than presenting detailed performance study results against specific criteria.

Ask a specific question about this device