Search Results

The Fusion FibFix Nail is intended for use in the fixation of fibula fractures and osteotomies.

The Fusion FibFix Nail consists of a titanium alloy (Ti6AI4V ELI (ASTM F136)) intramedullary fibula nail and threaded bone fixation fasteners for fixation of the ankle following trauma and osteotomy. The system includes corresponding instrumentation to support both insertion and removal.

The Fusion FibFix Nail system includes intramedullary fibula nails, screws and end caps. Fibula nails are offered in 3.7mm, 4.7mm and 5.7mm diameters with lengths ranging from 130mm to 270mm. The included screws are offered in 2.7mm with lengths ranging from 10mm to 22mm.

When clinically indicated, the system may be used in conjunction with adjunctive rigid or flexible syndesmotic fixation. Flexible syndesmotic fixation is provided by the Bolo Button System (K242091), and rigid fixation may be provided with 3.5mm and 4.0mm screws cleared under by the PolyLock Plating System (K211843).

All implants are intended for single use only. Instruments designed for bone removal are intended for single use only, such as: Drill bits, reamers, k-wires, percutaneous screw targeting system and guide wires.

N/A

Ask a specific question about this device

The Affixus Retrograde Femoral Nailing System is indicated for:

• Compound and simple shaft fractures
• Proximal, metaphyseal and distal shaft fractures
• Segmental fractures
• Closed supracondylar fractures
• Severely comminuted supracondylar fractures with articular involvement
• Fractures involving femoral condyles
• Comminuted fractures
• Fractures involving osteopenic and osteoporotic bone
• Pathological fractures
• Fractures with bone loss
• Pseudoarthrosis, non union, and mal union
• Periprosthetic fractures
• Poly trauma patients

The Affixus Retrograde Femoral Nailing System is part of the Affixus long bone nailing platform, designed for the treatment of a wide range of femoral fractures, from simple to complex. The system provides multiple locking options to support fracture stabilization and healing. All nails are made of type II anodized Ti-6Al-4V. The Affixus platform of instrumentation is designed to provide options and flexibility for many intraoperative approaches while maintaining ease of use and commonality.

N/A

Ask a specific question about this device

The Reselute Traditional Tibial Intramedullary Nail is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft, open and closed tibial shaft fractures, certain pre and post isthmic fractures and tibial malunions and non-unions.

The Reselute Tibial Intramedullary Nail System is a single use intramedullary device for the fixation, correction, or stabilization of the tibia. The Reselute Tibial Intramedullary Nail implant system includes a tibial nail offered at various diameters and lengths to accommodate a range of patient anatomies, cross-locking screws to prevent movement of the nail relative to the bone fragments, and optional endcaps for preventing proximal bone ingrowth. Each implant component is manufactured from titanium alloy (Ti-6Al-4V), which conforms to ASTM F136-13 for medical implants.

N/A

Ask a specific question about this device

The Arthrex FibuLock Nail System is intended for use in the fixation of fibula fractures and osteotomies.

The Buttress Plate is intended for use with the FibuLock PRO Nail and Arthrex TightRope Syndesmosis Devices to support additional stabilization for fibula fractures. The Buttress Plate is designed for use with the FibuLock PRO Nail and TightRope Syndesmosis devices and may not be used as a stand-alone device.

Not Found

N/A

Ask a specific question about this device

Not Found

Not Found

N/A

Ask a specific question about this device

The Active Intramedullary (AIM) Tibial Nail System is indicated for the following:

• Open or closed fractures of the tibial shaft
• Proximal or distal tibial shaft fractures
• Tibial shaft fractures including transverse, short oblique, long oblique, and comminuted fracture patterns
• Tibial non-unions and malunions
• Pathologic and/or impending fractures

The AIM Tibial Nail System is a tibial intramedullary fixation rod designed to be implanted proximally and distally to a fracture line. The system consists of the Intramedullary (IM) Nail and Interlocking Screws. The IM Nail is made from titanium alloy and includes an internal compression spring for compression force/axial movement.

N/A

Ask a specific question about this device

The Affixus Natural Nail Humeral Nail System nails are intramedullary nails intended for temporary internal fixation and stabilization of humeral fractures or osteotomies.

The Affixus Natural Nail Humeral Nail System is indicated for use in a variety of fractures, such as:

• Proximal fractures (proximal short and long nails only)
• Diaphyseal fractures (proximal long nails and antegrade/retrograde nails only)
• Open and closed fractures
• Comminuted fractures
• Nonunions and malunions
• Pathologic fractures

The Affixus® Natural Nail® Humeral Nail System consists of temporary fixation intramedullary nails designed for fixation and stabilization of fractures or osteotomies of the humerus. The nail restore the shape of intramedullary bone, and they are available in a variety of lengths and diameters to meet assorted patient needs. The humeral nails are used together with Bone Screws, Washers, and Nail Caps. Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass-through holes in the nail. A locking mechanism feature (CoreLock™) within the Proximal Humeral Nails provides the option to lock 4.0 mm diameter Blunt Tip Screws within the nail. CoreLock™ secures the screws against medial or lateral migration. The current design locks on the outer thread diameter of the screw, relying on friction. The Proximal Humeral Nails are made of Titanium alloy [Protasul®-64WF (Ti-6Al-4V) ISO 5832-3/ASTM F136] and C.P Titanium [Protasul®-Ti SO 5832-2/ASTM F67].

The reason for this submission is to introduce a design change of the CoreLock™ locking system in the Affixus® Natural Nail® Humeral Nails by replacing the teeth profile with a multiple thread pitch. The new design preserves the friction fit mechanism and adds a form-fit interaction for enhanced locking performance.

N/A

Ask a specific question about this device

ARIX Femur Nail System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).

Anti-Rotation Lag Screw and Telescopic Lag Screw in ARIX Femur Nail System are made of Titanium Alloy which meets ASTM F136 and only 'Anti-Rotation Pin' section of Anti-Rotation Lag Screw is made of Nickel-Titanium Alloy which meets ASTM F2063. ARIX Femur Nail System is provided Sterile or Non-Sterile.

N/A

Ask a specific question about this device