FDA Clearance for Wright Medical’s External Fixator

Wright Medical Group, Inc. is using the opportunity presented by this year’s AAOS meeting to tell us it has gained U.S. FDA 510(k) clearance to market its SALVATION™ External Fixation System.

Background

The external fixation system forms an integral part of Wright’s SALVATION™ Limb Salvage product portfolio, which includes the SALVATION™ Beaming System and the SALVATION™ 3Di Plating System. This comprehensive package is designed to address fractures, nonunions and complex foot and ankle deformities and is the first complete portfolio of products to be specifically indicated for use to treat neuropathic osteoarthropathy, a deformity (most commonly mid-foot collapse) that results from nerve damage in the foot or ankle.

Wright says it expects to initiate limited physician testing of the SALVATION™ External Fixation System to collect market assessment data in the second quarter of 2015.

The announcement comes alongside Wright’s cataloguing of its recent innovations, to be shown at the AAOS meeting, which is taking place at the Venetian/Sands EXPO in Las Vegas, Nevada this week.

These include its INFINITY® Total Ankle Replacement (TAR) System, the INBONE® II TAR System, the PROPHECY® Pre-Operative Navigation Alignment Guides and the ORTHOLOC® 3Di Flatfoot Plates.

Company comments

Robert Palmisano, president and chief executive officer, commented, “We have continued to expand our broad product portfolio to further extend our leadership position in foot and ankle. The INFINITY ankle’s lower profile design and straightforward surgical approach expands our access to less complicated primary cases and continues to be an important catalyst in the ongoing market conversion from fusion procedures to total ankle replacement. In addition, we have a unique future opportunity to address advanced reconstructive, limb salvage, and Charcot cases with our SALVATION product portfolio. Despite the large and growing population at high-risk of peripheral neuropathies, the Charcot market remains underserved in terms of a comprehensive solution. We are looking forward to collecting initial physician testing and market assessment data for our SALVATION product portfolio in preparation for a future product launch.”

Source: Globe Newswire

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