Integra LifeSciences Gets 510(K) Clearance

Medical devices company Integra LifeSciences Holdings Corp. has received 510(k) clearance from the U.S. Food and Drug Administration or FDA for its Vu aPOD Prime device used in the treatment of back pain of discogenic origin.

The purpose of a 510(k) is to demonstrate that the medical device to be marketed is substantially equivalent to a legally marketed device that was or is currently on the U.S. market.

The Vu aPOD Prime is an anterior lumbar interbody fusion or ALIF device. The goal of the device is to fuse vertebrae and reduce pain. ALIF procedures are most common for correction of degenerative disc disease or DDD. The U.S. market size for ALIF is estimated to be $425 million.

Integra said that the Vu aPOD Prime device allows for two fixation options. In the first option, the device can be secured in place with two self-tapping bone screws. It requires no additional supplemental fixation and dramatically reduces the number of operative steps when compared with other ALIF implants.

In the second option, the Vu aPOD Prime device can be secured with an internal buttress plate technology called SpinPlateTM, which requires supplemental fixation. Its anatomic shape and large graft window help to facilitate fusion.