AlloSource has received the US Food and Drug Administration 510(K) approval for its AceConnex Pre-Sutured Fascia for hip labral reconstruction and augmentation.
The AceConnex Pre-Sutured Fascia is a device used in soft tissue surgical procedures, where constructs are used for reconstruction, replacement, or augmentation of the labrum.
It is a ready-to-use, sterile device, offered in various pre-sutured sizes, with trimmable regions that facilitates allograft adjustments to conform with patients’ anatomy.
The AceConnex Pre-Sutured Fascia is manufactured to ensure consistency and minimise variability compared to other allograft products, which are manually sutured pre-operatively.
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.”
Established in 1994, AlloSource provides human tissue and develops advanced dermis, cartilage, tendon, fascia, bone, and amnion allografts to support healing in patients.
The non-profit organisation has been advancing its allografts to improve patient outcomes.
AlloSource is registered with the FDA as a tissue establishment and accredited by the American Association of Tissue Banks, serves as a trusted tissue partner to the medical community.
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.”
