Kuros Biosciences Announces FDA 510(k) Clearance for MagnetOs Easypack PuttyHeadline

Schlieren (Zurich), Switzerland, 9 September, 2021 – Kuros Biosciences (“Kuros” or the “Company”), a leader in next generation bone graft technologies, announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for 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 the FDA for the use of MagnetOs Granules and MagnetOs Putty in the spine.
Joost de Bruijn, Chief Executive Officer of Kuros, said: “The new formulation in the MagnetOs product family offers surgeons a broader set of options for perioperative properties. This latest successful regulatory milestone continues our track record of market clearances with the FDA and strengthens our position on the market.”
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.

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