Vendor/Manufacturer: In2Bones SAS
Product/Product Line: Ankle Fusion Plating System
FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3030
FDA Regulation Description Classification Name:
Single/multiple component metallic bone fixation appliances and accessories
FDA Classification Product Code: HRS
FDA Classification Product Code Device Name:
Plate, Fixation, Bone
SUBSTANTIALLY EQUIVALENT to the following products:
Device Description:
The Ankle Fusion Plating System is composed of an anatomically contoured plate, with a distal part adapted to the talar neck, and a proximal part adapted to the distal tibial epiphysis and diaphysis. Rigid fixation is achieved by screws.
The Ankle Fusion Plating System implants (plate and screws) are manufactured from Ti6Al4V. A dedicated instrument set is available for the bone preparation, screw sizing and insertion of the Ankle Arthrodesis Plating System. A specific targeting device is available for the insertion of the additional I.B.S® 6.5mm screw.
Sizes: The Ankle Fusion Plate is available in one size, with left and right versions. Fixation screws are available in 3.5 or 4.5mm diameter, with length ranging from 10 to 100mm.
Material: The Ankle Fusion Plating System implants (plate and screws) are manufactured from Ti6Al4V, as per ISO 5832-1 and ASTM F136.
Single use: The Ankle Fusion Plating System is designed for single use only.
Sterilization: The Ankle Fusion Plating System is supplied sterile, using gamma irradiation.
Place of use: The Ankle Fusion Plating System is indicated for use in a hospital, or outpatient surgery center where sterile field may be created and maintained.
Indications for Use:
The In2Bones Ankle Fusion plating system is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia, talus and calcaneus. The addition of a compression screw through the tibiotalar joint (example IBS™ 6.5mm screw) is required.
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