Green light from FDA for 3D printed lateral spine truss system

Frisco, Texas-based medical implant company 4WEB Medical has been at the fore of developing 3D printed implants within the United States, having already introduced a number of innovative 3D printed implant systems such as its Posterior Spine Truss System, the ALIF Spine Truss System, and the Cervical Spine Truss System. Now, with the announcement that their 3D printed Lateral Spine Truss System has also received 510K clearance from the Food and Drug Administration, the list of 4WEB implants continues to grow.

4WEB’s recently cleared implant, a lateral interbody fusion device, marks a step forward for lateral spine treatments as well as an advancement for viable 3D printed implant options. The device utilizes the company’s innovative “4WEB” geometry which has opened the doors in terms of creating lightweight, strong, and biocompatible implant structures. As with their previously approved orthopaedic implants, the new Lateral Spine Truss System is designed to promote “osseous incorporation” or bone growth through its porous, but strong, surface.

With the launch of the 3D printed Lateral Spine Truss System, 4WEB is offering a range of different implant sizes as well as integrated instrumentation. The FDA approved implants will also be packaged using a smart single-sterile wrapping, which will not only guarantee sterility, but will allow 4WEB’s product to be dispatched to other global markets where such packaging is required.

“The Lateral Spine Truss System represents a significant advancement in treatment options for lateral spine surgery,” said Frank Cammisa, MD, Professor and Chief Emeritus of the Spine Service at Hospital for Special Surgery in New York City. “As evidenced in recent porous metal product launches, many companies have failed to recognize the full design potential of what 3D printing brings to the orthopaedic arena. 4WEB’s proprietary truss implant technology leverages fundamental engineering principles in structural mechanics to address important clinical issues such as implant subsidence after lateral access surgery.”

Since its founding in 2008, 4WEB Medical has dedicated itself to the creation of top-of-the-line spinal and orthopaedic implants with the help of 3D printing technologies. According to the company, over 10,000 of their trusty truss implants have been used in surgeries since the year 2013, a number that will surely continue to grow. There is little doubt that now, with the approval of their latest spinal truss system, their innovative products will continue to advance both spinal treatments and 3D printed medical devices. Last year, the medical device company also made headlines for having completed Australia’s very first patient-specific 3D printed implant.

Continue to read on http://www.3ders.org/

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Open BioMedical Initiative

Open BioMedical Initiative

Global nonprofit initiative supporting the traditional Biomedical world engaged in the collaborative design and distribution of low-cost, open source and 3D printable Biomedical Technologies.
Open BioMedical Initiative
2016-07-31T10:29:21+00:00 August 1st, 2016|English, News|0 Comments

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