Xtant Medical Receives 510k Clearance for Expanded Indications of Irix-A

Register to receive a free U.S. Market Report Suite for Minimally Invasive Implants 2017 – MedSuite report synopsis and brochure

Xtant Medical Holdings, Inc. (NYSE American:XTNT), a leader in the development of regenerative medicine products and medical devices, recently announced that the U.S. Food and Drug Administration (FDA) has cleared product line extensions for the Irix-A interbody spacer. The clearance provides for the addition of three additional size configurations for an expanded market opportunity, and importantly, for use with allograft. This clearance is the second received during this quarter, and continues to strengthen Xtant Medical’s focus in providing a more comprehensive portfolio focused on regenerative care for the patient.

Xtant Medical’s Irix-A is a standalone interbody device used in anterior lumber interbody fusions. The current product line offers a titanium and PEEK composite implant, with the additional option of a titanium plasma coating for improved osseointegration with the spinal endplate, all with 8° or 12° of lordosis for alignment with the curvature of the spine. This new 510k clearance adds three additional degrees of lordosis, specifically 16°, 20°, and 24°, providing the surgeon with a wider variety of choices to correct the patient’s loss of lordosis and to improve sagittal balance. The FDA clearance also expands the indications of use to include use with allograft, such as Xtant Medical’s patented OsteoSponge, proprietary 3Demin, or OsteoVive viable cell allograft.

Read the press release here: https://globenewswire.com/news-release/2017/09/12/1118257/0/en/Xtant-Medical-Receives-510k-Clearance-for-Expanded-Indications-of-Irix-A.html

For Further Information
More on the MIS implant market in the U.S. can be found in a series of reports published by iData Research entitled the U.S. Market Report Suite for Minimally Invasive Implants. The suite covers reports on the following markets: MIS interbody devices, MIS pedicle screws, spinous process fixation, facet fixation, MIS sacroiliac joint fusion, spine endoscope and MIS spine instrumentation.

The iData report series on MIS implants covers the U.S. and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxembourg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about MIS implant market data, register online or email us at info@idataresearch.net for a U.S. Market Report Suite for Minimally Invasive Implants brochure and synopsis.

Leave a Reply