Kuros Biosciences Gains FDA 510(k) Clearance for MagnetOs Easypack Putty

By Julie A. Vetalice

Kuros Biosciences Gains FDA 510(k) Clearance for MagnetOs Easypack Putty

Kuros Biosciences received FDA 510(k) clearance to market MagnetOs Easypack Putty, a soft and moldable formulation ideal for packing into voids of the skeletal system, particularly the posterolateral spine during spinal fusion surgery.

The clearance of MagnetOs Easypack Putty follows existing clearances by FDA for the use of MagnetOs Granules and MagnetOs Putty in the spine.

Human-derived products, such as cell-based allografts, and recombinant protein products, such as bone morphogenetic proteins, need to be stored in freezers and then carefully thawed under strict protocol prior to or during surgery.

To the benefit of surgeons and their patients, MagnetOs Easypack Putty is provided in an open-ended dispenser and is ready to use with no need for thawing or mixing with blood or bone marrow aspirate. It can be stored at room temperature and used immediately from the packaging, which can save Operating Room staff vital time during procedures.

Source: Kuros Biosciences

Product Labels: Synthetic Bone Graft

Tags: 510(k) Clearance, Regulatory