The FDA has given the regulatory nod to the TM Ardis porous metal interbody implant from Zimmer Holdings (Warsaw, IN) for treating degenerative disc disease. The device was designed for use with autogenous bone graft for posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) of the anterior column of the spine.
The device, which is offered in 40 sizes, extends the company’s portfolio of products built on its proprietary Trabecular Metal technology, which mimics the elasticity of cancellous bone. The TM Ardis supports fusion of bony surfaces between the implant and bone to promote biologic fixation. The implant was also designed with an anatomical shape that facilitates insertion into the disc space.
The indications for the device are summarized in the 510(k) Summary (PDF) filed with FDA:
The TM Ardis® Interbody System is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-SI1) in the treatment of degenerative disc disease (DDD) with up to Grade I 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.
Zimmer had introduced the TM Ardis implant in May at SpineWeek 2012 in Amsterdam.
Press release: Zimmer Introduces First Porous Metal Interbody Implant for Lumbar Spine in the United States…