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Medicare receives FDA 510(k) clearances for components to address pediatric deformity

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Medicrea announced it has received FDA 510(k) clearances for its PASS XS posterior fixation and LigaPASS XS band connector components to treat pediatric spinal deformities in patients of small stature.

According to a company press release, the extra small “XS” extension technology in both components will allow surgeons to treat patients using 40% less implant volume. The PASS XS and the LigaPASS XS also reportedly have the lowest construct profile in-situ on the market and still offer similar technology as the PASS LP and LigaPASS systems used in adults.

“By adapting our industry-leading PASS and LigaPASS deformity systems for the unique requirements of pediatric deformity through the ‘XS’ components, Medicrea is continuing to strengthen its position as a leader in FDA-cleared personalized analytical services and implant solutions for the treatment of complex spinal conditions,” Denys Sournac, president and chief executive officer, said in the release.

Reference:

http://www.medicrea.com/usa/press-room/