FDA Clears Expanded Tactoset Indication

FDA has given an additional 510(k) clearance to Anika Therapeutics’ Tactoset injectable bone substitute. The company says the new indication expands the use of Tactoset to include augmentation of hardware and the support of bone fragments during surgical procedures.

Anika describes Tactoset as a calcium phosphate-based, biocompatible bone graft substitute that incorporates the company’s core hyaluronic acid. Once injected, Anika says, Tactoset hardens and mimics the properties of normal trabecular bone initially and remodels into healthy bone over time.

Since its launch in 2019, Tactoset has been used for the treatment of bone voids, insufficiency fractures, and other skeletal defects, often performed in an outpatient surgical setting. With this expanded indication, the company says, surgeons can use Tactoset in situations where augmenting hardware and/or bone fragments due to insufficient bone quality may be beneficial to their patients.