The device has been approved for hip labral reconstruction and augmentation. Credit: Alex Mit / Shutterstock.com.

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The 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.