Osseus Gains 510(k) for Pisces-SA Spinal Fusion

By Julie A. Vetalice

Osseus Gains 510(k) for Pisces-SA Spinal Fusion

Osseus announced FDA 510(k) clearance and launch of the Pisces™-SA Standalone ALIF Interbody System. Pisces-SA can be used with both bone screws and alternative fixation bone anchors allowing for increased intraoperative flexibility.

Biomechanical testing has indicated that Pisces-SA anchors provide better expulsion resistance than the competition and perform comparably with traditional screw-based standalone ALIF constructs in stabilizing injured spinal segments. Pisces-SA is reportedly the first of its kind to provide this level of expulsion resistance and segmental stabilization using an alternative fixation method.

Pisces-SA anchors allow for a streamlined, direct anterior approach which facilitates minimal access and improved operational efficiency.

The platform integrates a highly-porous 3D-printed interbody with anatomical morphology designed for full osseointegration with streamlined instrumentation to facilitate a minimally invasive approach.

Source: Osseus Fusion Systems

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory