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The Arsenal Ankle Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, distal tibia, fibula, and other bones appropriate for the size of the device.

The Arsenal Ankle Plating System consists of plates of various shapes and sizes composed of implant grade titanium alloy intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, distal tibia, fibula, and other bones appropriate for the size of the device. The system incorporates multiple locking and nonlocking screws of various lengths and diameters, washers, and the necessary instruments to facilitate the placement of these implants.

The Arsenal Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/ foot, ankle, and other bones appropriate for the device. The plates (implants), screws (implants), washers (implants), olive wires (instruments), and guide wires (instruments) are intended for single use only.

The Arsenal Plating System consists of plates of various shapes and sizes composed of implant grade titanium alloy intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device. The system will incorporate multiple locking and non-locking screws of various lengths and diameters, washers, and the necessary instruments to facilitate the placement of these implants.

The Two-Step Implant System is intended for fixation of osteotomies and reconstruction of the bones of the foot and hand during procedures to correct deformities of the toes and fingers. Indications include: hammer toe deformity, claw toe deformity, mallet toe deformity, and other deformities of the foot and hand.

The Two-Step Implant System is used for fixation of the bones of the foot and hand. The system includes a cannulated, threaded, spaded implant that is offered in multiple threaded diameters, lengths, and spade diameters. The system includes k-wire implants in multiple sizes. Available implants and instrumentation can be packaged in a sterilization tray as a single system. System instrumentation includes spade pilot drills, spade drivers, thread pilot drills, reamers, impactor, and handles to facilitate the placement of the implants. The Two-Step Implant System implants and k-wires are intended for single use only.

The Trilliant Sniper Staple System is indicated for fixation of fractures and osteotomies of the hand, foot, and bones appropriate for the size of the device.

The Sniper Staple System consists of different-sized staples composed of Nitinol (Nickel-Titanium alloy) intended for fixation of fractures and osteotomies of the hand, foot, and bones appropriate for the size of the device. The system will be offered non-sterile in a tray for sterilization at the user's facility prior to use.

The Minimally Invasive Bunion Plating System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

The Minimally Invasive Bunion Plating System consists of left and right plates composed of implant grade titanium intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus. The system will incorporate both locking and non-locking screws, cannulated screws, and the necessary instruments to facilitate the placement of these implants.

The Trilliant Surgical Sniper Staple System is indicated for fixation of fractures and osteotomies of the hand, foot, and bones appropriate for the size of the device.

The Sniper Staple is a mechanical osteosynthesis device allowing for fixation and compression of the bone fragments in order to encourage early bone healing. The staple is fabricated from a nickel-titanium alloy (Nitinol) and possesses super-elastic properties at room temperature. The staple offering is composed of staples consisting of a 1.5 mm x 1.2 mm diameter "U" shaped wire. The "U" shaped staple is available in 8 mm x 8 mm and 10 mm x 10 mm sizes.

The Gridlock Ankle Plating System is intended for use in trauma and reconstructive procedures of the hand/foot, ankle, distal tibia, fibula, and other bones appropriate for the size of the device. The plates (implant), screws (implant), olive wires (instrument), and guide wires (instrument) are intended for single use only.

Gridlock Ankle Plating System consists of various shape and size plates for the management of orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact, capability of dynamic/manual compression, and angulated-locking threaded screw holes. The system also consists of multiple locking/standard screw lengths and diameters and the necessary instruments to facilitate the placement of these implants.

The Tiger Cannulated Screw System is indicated for fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.

The Tiger Cannulated Screw System is a headed and headless, cannulated, self-drilling, self-tapping screw system for the management of bone orthopedic osteotomies and trauma. The system consists of Ø2.0-Ø7.0 mm screws and washers, and the necessary instruments to facilitate the placement of these implants. The purpose of this submission is to add Ø5.5 mm and Ø7.0 mm headed cannulated screws to the Tiger Cannulated Screw System and to modify the indications for use statement for previously cleared devices (K081510 / K112737).

The Gridlock Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device. The plates (implant), screws (implant), olive wires (instrument), and guide wires (instrument) are intended for single use only.

Gridlock Plating System consists of various shape and size plates for the management of orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact, capability of dynamic/manual compression, and angulated-locking threaded screw holes. The system also consists of multiple locking/standard screw lengths and the necessary instruments to facilitate the placement of these implants.

The Gridlock Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device. The plates (implant), screws (implant), olive wires (instrument), and guide wires (instrument) are intended for single use only.

Gridlock Plating System consists of various shape and size plates for the management of orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact, capability of dynamic/manual compression, and angulated-locking threaded screw holes. The system also consists of multiple locking/standard screw lengths and diameters and the necessary instruments to facilitate the placement of these implants.