Cervical Cage Cleared by FDA

A cervical interbody fusion system, designed for use in patients with degenerative disc disease at one disc level, has been cleared by the U.S. Food and Drug Administration (FDA). Called Bak/C, the system is the product of Sulzer Spine-Tech (Minneapolis, MN, USA). Sulzer states that this is the first cervical interbody fusion device to be cleared by the FDA.

The Bak/C device is a cylindrical titanium alloy implant, which may be placed between the third and seventh cervical vertebrae to provide stability and promote fusion between vertebral bodies. A multicenter study showed significantly higher fusion rates at every follow-up interval for Bak/C patients compared to patients with anterior cervical diskectomy and fusion (ACDF). Fewer complications were also reported in the Bak/C group: 17% compared to 25% in the ACDF group. The company notes that in addition to allowing a patient to avoid a painful bone graft harvest, the Bak/C eliminates the need for a plate device that may interface with the esophagus and cause swallowing difficulties.

"Most surgeons prefer to use bone harvested from the patient in cervical spinal fusion procedures. Due to its unique design, Bak/C collects local bone during implant insertion, resulting in autograft without the need for bone harvest from the patient's hip,” noted Rich Lunsford, president of Sulzer Spine-Tech.



Related Links:
Sulzer Medica