NovoSource Receives FDA Clearance for SteriKnee™ Single-Use Total Knee Instrument System

Sterile, Pre-Assembled Instrument Platform Designed to Provide an Alternative to Traditional Reusable Instrument Trays

MORGANTOWN, W.Va. – May 2026 – NovoSource, LLC announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for SteriKnee™, a sterile, pre-assembled, single-use instrument system designed for use with the NovoKnee Total Knee System.

Total knee replacement is one of the most commonly performed surgical procedures in the United States, with approximately one million procedures performed each year. Most of these procedures rely on large, heavy, reusable metal instrument trays that require extensive handling and significant resources to clean, sterilize, wrap, transport, store, assemble, and process between surgeries. A typical knee replacement procedure may require multiple instrument trays containing nearly one hundred instruments and components that must be managed throughout the surgical process.

“SteriKnee represents a new way of thinking about total knee replacement instrumentation,” said Doug Hawkins, Founder and CEO of NovoSource. “For years, surgeons, hospitals, and surgery centers have accepted the challenges associated with reusable instrument trays because there wasn’t another option. We believed there had to be a better way that can be safe, efficient, and cost-effective. SteriKnee was designed to simplify the process by providing sterile, pre-assembled instrumentation intended for one patient and one procedure.”

The SteriKnee reduces many of the logistical requirements associated with traditional reusable instrumentation. 

Potential benefits of the SteriKnee system include:

• Elimination of sterile blue-wrap processing costs and associated risks





• Reduction of missing, damaged, or instrument assembly errors





• Decreased instrument storage and transportation needs





• Simplified operating room setup and turnover





• Greater workflow consistency from case to case

The SteriKnee system is intended for use exclusively with the NovoKnee Total Knee System, which has been successfully utilized in thousands of procedures. By combining a proven implant platform with sterile, pre-assembled, single-use instrumentation, NovoSource is introducing an alternative to the reusable instrument model that has been the standard in orthopedic surgery for decades.

The introduction of SteriKnee comes as hospitals and ambulatory surgery centers continue to seek solutions that improve efficiency, reduce complexity, address staffing challenges, and support the continued migration of total joint procedures to outpatient settings.

NovoSource anticipates commercial availability of SteriKnee beginning in the summer of 2026 with an initial rollout to selected surgeons and healthcare facilities throughout the United States.

About NovoSource

NovoSource, LLC is a U.S.-based orthopedic device company headquartered in Morgantown, West Virginia. The company’s NovoKnee Total Knee System and NovoHip Total Hip System have been used successfully in thousands of procedures. NovoSource is pioneering sterile, pre-assembled, single-use instrumentation designed to simplify orthopedic surgery while helping hospitals and ambulatory surgery centers improve efficiency and reduce complexity.

For additional information, visit www.novosource.com.

Contact
NovoSource, LLC
Morgantown, WV
info@novosource.com