Stryker (NYSE:SYK) said yesterday it won expanded FDA 510(k) clearance for its VertaPlex HV PMMA to treat patients with sacral insufficiency fractures.
Sacral insufficiency fractures are an under diagnosed condition often occurring in the elderly population, the Kalamazoo, Mich.-based company said.
“Careful intraoperative technique and VertaPlex HV PMMA is an excellent and safe solution in the management of sacral fractures. This new FDA approved indication will benefit countless lives. I have already witnessed dramatic patient improvement in my own practice by incorporating sacral vertebroplasty/sacroplasty as part of my intraoperative protocol,” principal investigator Dr. Jeffrey Miller of Kalamazoo, Mich.’s Bronson Methodist Hospital said in a press release.
Stryker won its original 510(k) for the VertaPlex HV PMMA in June this year, claiming it is the 1st PMMA to receive clearance for the fixation of pathological fractures of the sacral vertebral body.
“As our population ages, we will see more sacral insufficiency fractures that will require intervention. Having a reliable and consistent high viscosity cement like VertaPlex HV will allow greater margin of safety for patients undergoing sacroplasty,” Dr. Douglas Yim of Baltimore, Md.’s Johns Hopkins School of Medicine said in a press release.
In August, Stryker said it recalled 16,992 orthopedic implant devices in an FDA Class II recall due to possible packaging compromises during transportation
The Class II label indicates that the device could create “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” according to the federal watchdog.
The units come from 5 different lines of products, with the FDA indicating the rHead, uHead, Sigmoid Notch, Remotion and Radio Capitellum devices for the recall.
