FDA Clears K2M’s YUKON™ OCT Spinal System

Complex and minimally invasive spine solutions company, K2M Group Holdings, Inc., has received U.S. FDA 510(k) clearance for its YUKON™ OCT Spinal System.

Background

YUKON OCT aims to facilitate fusion with posterior fixation in the occipito-cervico-thoracic regions of the spine with the goal of helping to achieve three-dimensional spinal balance.

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The system features newly designed top-loading, high angulation, polyaxial screws that provide up to 105 degrees of polyaxial angulation. YUKON OCT screw heads accept both Ø3.5 & Ø4.0 mm rods in both cobalt chrome and titanium, and accommodate construct rigidity based on degenerative or deformity corrections. Square thread set screws facilitate screw introduction and minimize the potential for cross-threading, while an updated occipital plate features integrated lateral holes with the goal of enhancing occiput fixation.

YUKON OCT’s advanced, streamlined reduction instrumentation allows for intraoperative flexibility and ease of use. The pistol grip style Rod Reducer provides 20 mm of reduction, while the Sequential Reducers deliver 20 mm of controlled reduction and correction.

The system complements K2M’s Balance ACS (BACS™) platform, which addresses each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes. K2M’s ultimate goal is to achieve three-dimensional Total Body Balance™.

Physician comments

“The YUKON OCT System expands on K2M’s current offering while accounting for the challenging posterior cervical cases surgeons often treat,” said Chambliss Harrod, MD, a spine and orthopedic surgeon at the Bone & Joint Clinic of Baton Rouge. “Unlike systems that feature only highly favored angulation screw designs, YUKON OCT is a comprehensive system that offers surgeons the ability to treat a variety of spinal conditions—including routine degenerative cases, revisions, and complex cervical deformities.”

Company comments

“We are pleased to announce FDA clearance of the YUKON OCT Spinal System and the successful completion of its first surgical cases,” said K2M President and CEO Eric Major. “K2M is a global leader in spinal innovation and YUKON OCT is our new solution that deepens our expanding portfolio of spinal devices for the occipito-cervico-thoracic region of the spine. Accompanied by our comprehensive Balance ACS™ platform, YUKON OCT offers a competitive surgical solution with the goal of achieving Total Body Balance for patients.”

Source: K2M Group Holdings, Inc.

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