K2M Receives FDA Clearance for YUKON OCT System

By Julie A. Vetalice

K2M received FDA 510(k) clearance to market the YUKON™ OCT system to support fusion with posterior fixation in the occipito-cervico-thoracic spine. First surgical cases have been completed.

YUKON's top-loading high angulation polyaxial screws provide up to 105º of polyaxial angulation. Screw heads accept 3.5 and 4.0mm rods in cobalt chrome and titanium, and accommodate construct rigidity based on degenerative or deformity corrections. Square thread set screws minimize the potential for cross-threading, and an updated occipital plate features lateral holes to enhance occiput fixation.

Instrumentation includes a pistol grip-style Rod Reducer for 20mm of reduction and Sequential Reducers that deliver 20mm of controlled reduction and correction.

Source: K2M, Inc.

 

 

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory