FAQ
What is ROTIUM® Bioresorbable Wick and how does it work?
ROTIUM® is a fully synthetic, bioresorbable scaffold designed to be placed at the tendon-bone interface during tendon repair surgery to support the healing response. It acts as an interpositional wick that retains the patient’s own biologic factors at the tendon-bone interface or around a tendon, promoting native tissue remodeling rather than scar formation. ROTIUM has been utilized in over 12,000 rotator cuff procedures, with ongoing clinical studies supporting its safety and performance. ROTIUM is FDA-cleared for the management and protection of all tendons.
Can ROTIUM® be used for tendon repairs beyond the shoulder?
Yes. ROTIUM® is FDA-cleared for a wide range of tendon repair procedures beyond rotator cuff repairs, including hip, knee, elbow, wrist, hand, foot, and ankle tendon repairs. ROTIUM supports healing by enhancing the biologic environment, providing a scaffold that retains biologic factors and mimicking the native extracellular matrix of the surrounding tissues.
How does BioCharge® differ from ROTIUM®?
While both are bioresorbable implants, BioCharge® is designed for use on the bursal side of rotator cuff repairs. With a built-in delivery system and suture tunnel, it is designed to reinforce the tendon-suture interface and reduce the risk of suture cut-through. ROTIUM®, by contrast, is placed at the tendon-bone interface or around tendons to support biologic healing at the enthesis.
Do these implants require special instruments or additional surgical time?
No. Both ROTIUM® and BioCharge® are designed with efficiency in mind to integrate seamlessly with standard surgical techniques. ROTIUM does not require additional disposables or instrumentation, and BioCharge features an integrated delivery system for simplified arthroscopic implantation.
What clinical data supports the use of ROTIUM®?
The technology behind these products has been researched for almost 15 years. There are multiple clinical and preclinical studies supporting the use of ROTIUM®. Notable examples include the pivotal sheep study led by surgeon investigator Dr. Anthony Romeo (see more in Rotium Animal Studies Brochure) and the peer-reviewed clinical study by Dr. Brian Badman, published in the Journal of Orthopaedic Experience & Innovation (Badman_JOEI_2023.pdf). You can explore and download additional publications and clinical resources on our Downloads Page.
Are ROTIUM® and BioCharge® FDA-cleared?
Yes. Both ROTIUM® and BioCharge® are FDA-cleared Class II medical devices under the 510(k) pathway. This means the FDA has reviewed and cleared them for their intended surgical uses based on substantial equivalence to legally marketed predicate devices.
What are ROTIUM® and BIOCHARGE® made of?
Both products are made from well-characterized biocompatible synthetic polymers Poly Glycolic Acid (PGA) and Poly Lactide co-Caprolactone (PLCL). These bioresorbable polymers have a robust safety profile and are designed to gradually resorb over 3–6 months as the body heals. The implants are designed for use with almost any suture anchor. Surgeons should follow proper indications for use and consult full Instructions for Use (IFU).
How can I request a product demo or more clinical data?
Visit our Contact Page to connect with our clinical and sales teams. You can view peer-reviewed publications, IFUs, surgical techniques and more on our Resource Page.