FDA Approves Ventris Medical's First-of-Its-Kind 510(k) Clearance for Backpack® Bone Graft System.
Ventris Medical has announced that the United States Food and Drug Administration (FDA) has granted 510(k) clearance for its Backpack® Porous Biologic Scaffold (K240765). Backpack® introduces a novel category of biomaterials aimed at enhancing cell proliferation and bone formation, specifically designed for use in orthopaedic and spinal fusion procedures.
The product is available in two versions: one prefilled with Allocell® AF fibres and the other with Amplify® granules, both enclosed in a collagen mesh pouch.
The Backpack® AF version contains osteoinductive Allocell® AF allograft fibres fully enclosed within a collagen mesh pouch. This 100% biologic graft system integrates both the containment pouch and the allograft fibres into the bone remodelling process.
The Allocell® AF fibres provide a scaffold-like structure that promotes cell attachment and proliferation, supporting the body’s natural healing mechanisms.
Additionally, these fibres actively encourage stem cells to differentiate into bone-forming cells, enhancing bone regeneration. Backpack® AF is supplied in a ported pouch for hydration and is ready for immediate use, streamlining surgical procedures.
The Backpack® AMP version is prefilled with surface-activated Amplify® granules. These biphasic granules, enclosed within the collagen mesh pouch, feature a hybrid mixture of two distinct hydroxyapatite-to-βTCP blends.
The Backpack® platform integrates osteoinductive allograft fibres and patented surface-activated biphasic mineral components within a biologic containment system, offering a unique anti-migration feature. This innovative approach enhances graft stability and improves outcomes in bone fusion procedures.
By combining these elements, Ventris Medical continues to advance its portfolio of orthobiologic solutions, demonstrating its commitment to developing next-generation devices that improve both surgical outcomes and the user experience.
The clearance of Backpack® represents a significant milestone for Ventris Medical, reinforcing its position as a key innovator in the orthobiologics field. This technological advancement provides a strong foundation for future product developments aimed at optimising bone graft technology and enhancing patient care.
Source: https://www.businesswire.com/news/home/20250107507232/en/AccurKardia-Receives-FDA-Breakthrough-Device-Designation-for-AI-powered-Hyperkalemia-Detection-Solution-Using-Lead-I-ECG-Data
