Astura Medical receives FDA 510(k) clearance for SIRION LLIF system


Astura Medical has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Sirion lateral lumbar interbody fusion (LLIF) system.

From initial access with the retractor to the interbody and plating options, the Sirion LLIF system delivers unprecedented intraoperative flexibility and efficiency by providing a complete procedural solution for lateral surgery driven by surgeon preference, Astura Medical said in a press release.

“Since the outset of the design process, our goal was to develop a system that could address the wide array of procedural and anatomical challenges presented in lateral surgery,” said Thomas Purcell, co-founder and vice president of Astura Medical.

The launch of Sirion represents the first platform from Astura with a combined interbody and fixation option in a single system. The company is scheduled to release additional combined technology for anterior lumbar interbody fusion (ALIF) and anterior cervical discectomy fusion (ACDF) in the coming months.


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