Anika Therapeutics receives FDA 510(k) clearance for injectable bone substitute
Anika Therapeutics Inc. has announced FDA 510(k) clearance for Tactoset, an injectable bone substitute designed to augment suture anchor fixation, according to a company press release.
Tactoset is a calcium phosphate-based bone graft substitute that features a hyaluronic acid (HA) core for easy injection, according to the release.
“Poor quality bone and suture anchor pullout is a real problem for patients in our industry, and surgeons can now use Tactoset to augment their suture anchor fixation and reinforce it from inside the bone. We’ve taken our proprietary HA-enhanced Tactoset and opened an untapped market in the area of augmentation of hardware including soft tissue suture anchors,” Ben Joseph, vice president of U.S. commercial and global brand management at Anika Therapeutics, said in the release. “Tactoset is a key growth driver within our current regenerative solutions portfolio, and this augmentation clearance highlights the transformation of Anika as a joint preservation and restoration company. We have big plans for Tactoset in the market and expect to have additional indications coming in the future,” Joseph added.