AlloSource has received 510(K) clearance from the US Food and Drug Administration (FDA) for its AceConnex Pre-Sutured Fascia for hip labral reconstruction and augmentation.
The device has been created for use as a component in soft tissue surgical procedures.
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It is predominantly used in the reconstruction, replacement or augmentation of the labrum, specifically when utilising constructs that include allograft tissue.
AlloSource product development, innovation and clinical affairs senior director Carolyn Rorick said: “AceConnex Pre-Sutured Fascia was designed to help hip arthroscopists efficiently treat their patients by eliminating time and tedious effort associated with suturing in the OR.
“We spent an extensive amount of time perfecting our design and suturing technique to ensure consistency and that design is now patented.”
The company will offer the ready-to-use and sterile device in multiple pre-sutured sizes, with trimmable regions, which enable allograft adjustments to match the anatomy of the patient.
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By GlobalDataThe device is manufactured to achieve consistency and reduce variability when compared to manually sutured allografts pre-operatively.
AlloSource president and CEO Dean Elliott said: “AceConnex Pre-Sutured Fascia is integral to our mission of providing innovative allografts to advance patient healing.
“We are proud to be first to market with an FDA-cleared pre-sutured fascia device to meet the varying needs of hip arthroscopists and patients.”
Founded in 1994, the company is involved in the development of dermis, cartilage, tendon, fascia, bone and amnion allografts.
