The company will submit a PMA amendment for the Augment, and CDRH will determine if the PMA is approvable no later than 180 days after the amendment is received.
By Jim Dickinson
CDRH and Wright Medical have reached an agreement for the company to submit a PMA amendment for its Augment Bone Graft in lieu of seeking formal dispute resolution that was scheduled for a May 19, 2014, panel discussion.
The PMA amendment will include an analysis of preexisting radiographic films of clinical study patients at preoperative and postoperative time points, according to the company. CDRH has also agreed to issue a determination on whether the PMA is approvable no later than 180 days after the amendment’s submission.
Last year, FDA issued Wright Medical a “not approvable letter” on the original PMA for Augment and its use as an alternative to autograft in hindfoot and ankle fusion procedures.
In the letter, the agency said it is “concerned that the population enrolled was predominantly low risk and, therefore, may not have warranted the use of either autograft or Augment Bone Graft,” according to the company.
FDA called for a new clinical study that evaluates the device as a “substitute for autograft in hindfoot and ankle fusion procedures in a well-defined high-risk target population, where the use of autograft would be clinically warranted.”
“In summary,” the company said at the time, “the FDA concerns included ‘the patient population studied in the clinical study, the amount of graft material implanted, and the uncertainty as to whether any graft material would be needed or if the use of no graft material in a fusion procedure of the hindfoot and ankle in the population studied would have achieved similar results.’ FDA provided a number of additional observations about the clinical study design and results.”
Jim Dickinson is MD+DI's contributing editor.
[image courtesy of ADAMR/FREEDIGITALPHOTOS.NET]