Peleton Surgical Receives First-Ever FDA Clearance to Market Innovative Single-Use Surgical Power Driver
Peleton’s surgical power innovation program enhances financial control, improves surgical flexibility, and reduces patient risk
SCOTTSDALE, Ariz., April 10, 2024 – OrthoSpineNews – Peleton Surgical today announced that it has received FDA clearance (K240071) to market its innovative single-use surgical power driver. The costs and patient risk associated with re-usable surgical drivers represent a challenge for healthcare facilities, and Peleton Surgical’s solution will improve patient safety, enable better economics, and ease workflows for surgeons and staff. The elegant design of the Peleton single-use power driver offers great precision and ergonomics, and the power driver is launched with a patented solution for charging the driver through the sterile barrier of the packaging. The drivers and accessories are delivered to the surgery centers and hospitals fully charged, sterile and ready to use in the operating room.
“We listened to surgeons, nurses, and administrators when designing our breakthrough single-use surgical power driver and attachments. The integrated battery pack solves a lot of practical challenges for OR staff and actually helps reduce cost per use,” says Andy Bala, CEO and Director at Peleton Surgical. “At the same time, we were able to address nurse, surgeon, and SPD concerns about patient safety related to the reprocessing of reusable drivers and their attachments.”
The FDA clearance is the first-ever for a single-use surgical power driver, and FDA created a new product category to pursue the evaluation and clearance for the device. Peleton surgical wanted FDA to undertake a thorough review of functional and safety data associated with the use of a surgical power driver, to create standards in an area where improper cleaning and frequent battery charges can result in patient risk and operational inefficiencies. As a result, Peleton went through very extensive testing prior to FDA clearance being granted. Testing involved the surgical driver, its attachments, and its accessories, all from leading surgical power driver manufacturers.
About Peleton Surgical
Peleton Surgical is a surgical power company founded in 2019. The company is focused on enabling surgeons and healthcare facilities to improve efficiencies and reduce costs while ensuring patient safety. Peleton’s innovative surgical power solutions improve financial control, versatility, and patient safety. It’s power simplified. The company recently received the first-ever FDA clearance for a single-use power driver.
