Foundation Surgical’s lateral interbody system earns FDA nod: 3 notes

Foundation Surgical earned FDA 510(k) clearance for its Interwedge standalone lateral interbody system.

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Three things to know:

1. The device can be used in conjunction with the company’s LLIF 180 procedure, according to an Oct. 4 news release. The LLIF 180 procedure is a bilateral-fixated standalone-lateral procedure.

2. The Interwedge’s deployable system makes the LLIF 180 procedure possible and is designed to provide ipsilateral and contralateral fixation.

3. The device and procedure help facilitate a lumbar spinal fusion without the need for  supplemental posterior fixation.

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