FDA grants clearance to World's First 4K Single-Use Surgical Arthroscope

The US Food and drug administration (FDA) has granted 510(k) clearance to Summit arthroscope, a single-use device that features 4K resolution for arthroscopic procedures. Pristine Surgical has received the clearance for world's first single-use surgical arthroscope.

Summit combines a 4K single-use surgical arthroscope with cloud-based software-Pristine Connect™-to deliver a high-definition image, every time, with a device that is always new and never obsolete. The scope is simple to set up and 100% sterile, ensuring patient and staff safety. Its transparent pricing model and automated inventory management also improve predictability and workflow.

“The Summit single-use arthroscope represents a new paradigm in arthroscopy, improving a procedure that hasn’t changed much in my 42 years of practice and beyond,” said Dr. Stephen Snyder, chief medical officer of Pristine Surgical and a recognized pioneer in the field of arthroscopy. “We’re removing the well-known barriers of legacy, reusable systems that eventually become obsolete by offering a new 4K single-use scope that improves safety and reliability while decreasing room turnover time and the cost of arthroscopic treatment.”

Pristine Surgical developed the Summit single-use arthroscope to address challenges inherent to conventional surgical visualization, which are complex and expensive, and feature reusable arthroscopes that are difficult and costly to maintain. Prone to wear, damage, and potential infection, these scopes can bring inefficiency and variability into the operating room.

“Summit simplifies arthroscopic procedures, offering a fully integrated single-use scope with 4K resolution that’s one-of-a-kind,” said Bryan Lord, CEO of Pristine Surgical. “Our FDA clearance is a significant milestone for the company. More importantly, it means that we can now begin offering the benefits of these single-use devices to surgeons and staff, and bring our single-use, cloud-based platform to more than 125 million endoscopy patients treated worldwide each year.”

Pristine Surgical expects to launch the Summit single-use arthroscope during the first quarter of 2023 with a predictable and transparent subscription pricing model and a convenient, automated re-ordering system. Through industry leading sustainability partnerships, Pristine Surgical will also provide recycling options to its customers.