FDA Panel To Review Zimmer PMA For Dynesys Spine Stabilization System

Full article reprinted from "The Gray Sheet" - October 12, 2009

Zimmer will argue for PMA approval of its Dynesys dynamic spinal stabilization device Nov. 4 in front of FDA's Orthopaedic and Rehabilitation Devices panel.

FDA Panel To Review Zimmer PMA For Dynesys Spine Stabilization System

Full article reprinted from "The Gray Sheet" - October 12, 2009

Zimmer will argue for PMA approval of its Dynesys dynamic spinal stabilization device Nov. 4 in front of FDA's Orthopaedic and Rehabilitation Devices panel.

Dynesys has been on the market since 2005 as a 510(K)-cleared device as an adjunct to fusion surgery, providing "added stability [to] keep the vertebrae in a more natural position than can be achieved with conventional surgery alone," according to the company.

The PMA seeks labeling for the device for use independent fusion surgery to stabilize the spine and preserve some patient mobility.

Specifically, Dynesys claims to "provide spinal alignment and stabilization in skeletally mature patients at one or two contiguous levels from L1S1," according to FDA's Oct. 6 Federal Register notice announcing the panel meeting.

The device, which uses flexible materials to enhance mobility, is the U.S. market leader in the dynamic pedicle screw system space.

It has more than a dozen competitors, though, and all of them including Zimmer were hit last week with a new mandate from FDA to collect post-market data on their 510(k) devices (see ¹ previous story).

FDA says it has reports of the device components loosening or breaking, sometimes necessitating additional surgeries.

The recent FDA order specifically targets the 510(k) fusion adjunct indication, but its impact on Zimmer's and other companies' prospects for achieving PMA approval for the standalone labeling is unclear.

- Ingrid Mezo

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