After Setbacks, IsoTis Gets 510(k) Approval for Accell
BY LAUREN UZDIENSKI, AUGUST 20, 2007
IsoTis announced this morning that the Accell family of products has been granted 510(k) approval by the FDA as a Class II device. The clearance follows nearly a year of back-and-forth between IsoTis and the FDA over the nature of Accell and illustrates some of the regulatory challenges of marketing biologics.
Accell is a patented DBM platform that was first marketed in the U.S. in 2005 as a Class II device called Accell Connexus (which later became known as Accell Plus.) IsoTis determined that additional Accell products, Accell Putty and Accell TBM, were HCT/Ps and thus did not require 510(k) clearance to be sold. Allograft and DBM are traditionally classified as HCT/Ps. However, because of "uncertainty" surrounding the definition of an HCT/P, IsoTis included Accell Putty and Accell TBM in a 510(k) application for the Accell family of products.
In October of 2006, while the 510(k) was pending, IsoTis received a written determination from the FDA that Accell Putty was not eligible for HCT/P regulation. The 510(k) review stalled until IsoTis met with the FDA and clarified the agency's questions about the Putty and TBM in a supplement.
The review was re-started in May of 2007, with the entire Accell family under consideration as Class II devices. This morning's positive announcement is the result of this review, which is good news for Integra Lifesciences as well: Integra plans to merge with IsoTis in a deal that is expected to close in the fourth quarter of 2007.
