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The MDS Distal Radius Plating System is internal fixation of fractures of the distal radius.

This special 510(k) submission is intended to add new plate designs, screw diameter options and lengths, pegs, and accompanying instrumentation to the Miami Device Solutions Distal Radius Plating System cleared through K161292/K162635. The Distal Radius Plating System is an internal fixation system to be used for the treatment of distal radius fractures. The system consists of plates, screws, pegs, and locking caps. The Distal Radius Plates are available in bilateral and side-specific designs to accommodate different anatomies and fracture patterns. The addition of new devices through this special 510(k) provides the user with more options for fixation. Materials: Ti-6Al-4V ELI alloy conforming to ASTM F136.

The MDS Plating System is internal fixation of fractures of various bones such as the clavicle, olecranon. humerus, radius, ulna, distal tibia, and for use in fixation of periprosthetic fractures. The system can be used with commercially available cerclage of material compatible with system implants including titanium alloy and cobalt chromium. The Low Profile Head Screw is used independently and is internal fixation of fractures of the clavicle, olecranon, humerus, radius, ulna, distal tibia, fibula as well as foot and ankle.

The MDS Plating System is an internal fixation system intenal fixation of fractures of various bones. The system consists of the following single-use implants: - Straight (broad and narrow) and pre-contoured plates available in a variety of sizes - - -Screws of various lengths and diameters, some of which are identified in previously cleared premarket notifications (K141493, K161292/K162635, and K162898). - Locking Caps of various diameters identified in previously cleared premarket notifications -(K141493, K161292/K162635, and K162898). - Low Profile Head Screws - - -Threaded cerclage buttons of various diameters used in conjunction with MDS plates to augment fracture stabilization. Additionally, the system includes single use and reusable instruments. Materials: Titanium alloy and Stainless Steel.

The MDS Olecranon Plating System is intended for internal fixation of fractures of the Olecranon.

The Olecranon Plating System is an internal fixation system to be used for the treatment of Olecranon fractures. The system consists of plates, screws, and locking caps, as well as single use and reusable instruments. The Olecranon plates are pre-contoured and side-specific, available in two different sizes; 2 hole and 4 hole. The Olecranon Plating System Screws are 2.7mm in diameter and available in various lengths. The MDS implants are single-use ONLY. Materials: Titanium alloy and stainless steel

The MDS Distal Radius Plating System is intended for internal fixation of fractures of the distal radius.

This special 510(k) submission is intended to add the following device instruments and caddy as accessories to the Miami Device Solutions Distal Radius Plating System which was cleared in K161292: 1. Polyaxial Drill Guide 2. Polyaxial Drill Guide Sleeve for K-Wire 3. Polyaxial Drill Guide Caddy The polyaxial drill guide caddy holds polyaxial drill guides and polyaxial drill guide sleeves for Kwires. The polyaxial drill guide and the polyaxial drill guide sleeve for K-wire helps the user during drill and K-wire insertion. The Distal Radius Plating System is an internal fixation system to be used for the treatment of distal radius fractures. The system consists of plates, screws, and locking caps. The Distal Radius Plates are bilateral and available in two different models; standard or with a multi-directional oblong hole (MDOH) feature. Each model comes in two sizes, 5 hole and 6 hole. The Distal Radius Plating System Screws are 2.7mm in diameter and available in various lengths.

The MDS Distal Radius Plating System is internal fixation of fractures of the distal radius.

The Distal Radius Plating System is an internal fixation system to be used for the treatment of distal radius fractures. The system consists of plates, screws, and locking caps. The Distal Radius Plates are bilateral and available in two different models; standard or with a multi-directional oblong hole (MDOH) feature. Each model comes in two sizes, 5 hole and 6 hole. The Distal Radius Plating System Screws are 2.7mm in diameter and available in various lengths. The MDS device is single-use ONLY. Materials: Ti-6A1-4V ELI alloy conforming to ASTM F136.

The Cannulated Screw for the Proximal Humerus Plating System is indicated for internal fixation of fractures of the proximal humerus.

The Miami Device Solutions (MDS) Cannulated Screw is a cannulated bone screw intended for use with the MDS Proximal Humerus Plating System cleared in K141493. The MDS cannulated bone screw is 3.5 mm in diameter, 30 to 60 mm in length in 3 mm increments, fully cannulated and threaded, and can interface with MDS Proximal Humerus Plates and Locking Caps cleared in K141493. The MDS device is supplied not sterile and is single-use only. Materials: Ti-6Al-4V ELI alloy conforming to ASTM F136.