The TM Ardis implant is a single device manufactured wholly from
Trabecular Metal™ (porous tantalum) material, a highly porous,
three-dimensional biomaterial designed for biologic fixation. The TM
Ardis implant is a convex, straight TLIF or PLIF device for interbody
fusion of the anterior column of the spine. TM Ardis is designed for
fusion at one or two contiguous levels in the lumbosacral region
(L2-S1). The superior and inferior surfaces of the device are textured
and convex to provide increased stability. The device also has two
slots on the posterior end of the device to mate with the insertion
instrument. The height is measured at the device’s tallest point.
These implants are intended for single use only and must not be
reused under any circumstances.
The TM Ardis system contains implants, offered in a variety of
cross-sectional geometries and sizes to accommodate different patient
anatomy and physician preference, and instrumentation for insertion
and neural element protection. Additionally, the TM Ardis System
utilizes the Ardis Instrumentation System for site preparation and trailing.
The Ardis instrumentation system (refer to 07.01471.001 for
instructions for use) is comprised of instruments and perforated
instrument cases that are generally comprised of aluminum, stainless
steel, and/or polymeric materials.
The instrument cases may be multi-layered with various trays,
holders and silicone mats to hold surgical instrumentation in place
during handling and storage.
The perforated instrument cases allow sterilization of the contents
to occur in an FDA cleared steam autoclave utilizing a sterilization
cycle that has been validated by the user for equipment and procedures
employed at the user facility. Instrument cases do not provide a
sterile barrier and must be used in conjunction with an FDA cleared
sterilization wrap to maintain sterility.