Medical Device Link.

An FDA orthopedic devices advisory panel unanimously recommended approval of Johnson & Johnson’s ceramic-on-metal hip bearing implant. In a 5-0 vote, the panel suggested approval of the Pinnacle CoMplete Acetabular Hip System, with conditions that include a 10-year follow-up study.

The panel made its recommendation after reviewing a two-year study that compared the Pinnacle’s safety and effectiveness with a DePuy metal-on-metal implant. The study revealed no significant difference between adverse events, revision rates, or survivorship after two years.

If approved, the device would be intended for patients who experience severe pain and disability as a result of osteoarthritis or posttraumatic arthritis. It would also be the first implant to use ceramic-on-metal instead of metal-on-metal.

For more details, visit the Med-Tech Precision blog.