This interbody fusion system offers the benefits of Trabecular Metal™ Technology with a modern, anatomical shape. The easily inserted TM Ardis Interbody System facilitates an efficient, reproducible spinal fusion procedure with a self-distracting nose, convex geometry and wide range of sizes. The unique interbody system is designed for versatility – it can be used in a variety of open or MIS surgical applications.
This system is made from the only material that offers up to 80% porosity, stability, and flexibility - Trabecular Metal Technology. This interbody fusion device offers an osteoconductive scaffold which allows for boney in-growth into the material of the implant, a high coefficient of friction to help prevent migration and expulsion, and a low modulus of elasticity allowing for more normal load transfer.
No other porous material so closely resembles the structure, function and physiology of trabecular bone.
Trabecular Metal Material is a highly porous structure with a nano-textured strut architecture that creates an initial scratch fit and facilitates the long-term biologic attachment of orthopaedic implants via the potential for bone ingrowth. Trabecular Metal Material is the most advanced fixation surface available for orthopaedic implants. Clinical use since 1997 demonstrates that this innovative technology provides excellent initial scratch fit and stable, long-term fixation. No other porous metal material so closely resembles the structure, function and physiology of cancellous bone.
Learn more about Trabecular Metal Technology at tmt.zimmer.com.
Trabecular Metal has a coefficient of friction of .98 against cancellous bone. This produces a good “scratch fit” and increases the material’s initial fixation and stability to bone. Good initial fixation secures the implant in place, allowing time for bone ingrowth.
Trabecular Metal Material has more than 10 years of clinical results and has been used in over 200,000 orthopedic cases worldwide.
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.
The TM Ardis Interbody System is indicated for use as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2- S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment. The TM Ardis Interbody System is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.
As with any surgical procedure, certain complications may result.