Dynesys Goes to Ortho Panel
The FDA's Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee will hold one of their rare meetings on November 4 to consider Zimmer's Dynesys Spinal System.
According to Zimmer's Web site, "The Dynesys Dynamic Stabilization System combines the surgical approach of traditional fusion with the philosophy of dynamic stabilization, using flexible materials to stabilize the spine while preserving anatomical structures. The result is dynamic stabilization that allows the surgeon to preserve much of the spinal anatomy. It accommodates a familiar surgical approach and minimally invasive techniques in a range of patients -- including those with acute and chronic instabilities caused by degenerative changes in the intervertebral discs.
The Committee will discuss, make recommendations and vote on Zimmer's premarket approval application. The FDA will then make a final determination on approval of the device. Zimmer's application states the system is indicated to provide spinal alignment and stabilization in skeletally mature patients at one or two contiguous levels from L1-S1.
This Panel meeting takes place 30 days plus one after the FDA issued Post-Market Surveillance (section 522) orders to all companies with marketing clearance for “dynamic stabilization systems” intended to provide support to the spine during fusion. Zimmer received letters for the Dynesys System implants, which are cleared for use in fusion procedures.
Zimmer spokesperson Brad Bishop told OTW that the FDA order does not directly impact their PMA submission as they are seeking approval for a non-fusion indication. The FDA request addresses dynamic stabilization in fusion procedures.
The FDA will make background materials available to the public no later than two business days before the meeting on its Web site, www.fda.gov/AdvisoryCommittees/Calendar/default.htm.
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