Search Results

The Acumed Ankle Plating System contains orthopedic plates and lag screws intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula, particularly in osteopenic bone.

The Acumed Small Fragment Base Set contains orthopedic plates and screws with the following indications: Acumed Hook Plates and Locking Peg Hook Plates are intended for fixation of fractures, osteotomies, and non-unions of small bones including the ulna, radius, tibia, and fibula. Acumed Fragment Plates and 4.0mm Cancellous Screws are intended for fixation of fractures, osteotomies, non-unions, replantations, and fusions of small bones and small bone fragments. Acumed One-Third Tubular Plates are intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.

The Acumed Ankle and Small Fragment Base Set Update introduces new 2.7mm and 3.5mm variable angle screws for use with previously cleared plates from the Acumed Ankle Plating System (K143385) and Acumed Small Fragment Base Set (K143394). Additionally, this submission expands the Ankle Plating System to include use of existing 2.7mm and 3.5mm non-locking screws in independent bone fixation, for the K143385 indications.

This is a 510(k) premarket notification for a medical device, not an AI/ML medical device. As such, the document does not contain information about acceptance criteria, study details, or other specifics related to AI/ML device performance or validation. The information provided is for metal bone fixation appliances and accessories.

Therefore, I cannot provide the requested information.

Ask a specific question about this device