Winter Innovations Receives FDA 510(k) Clearance and PCCP Authorization for Expanded EasyWhip® Family

KNOXVILLE, Tenn. — July 8, 2026 — Winter Innovations, Inc., a medical device company developing innovative solutions for orthopedic soft tissue surgery, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the expanded EasyWhip® Family.

The EasyWhip® Family builds on Winter Innovations' flagship EasyWhip® technology, a two-part needle system designed to facilitate easy, fast, and accurate stitch placement with less variation in orthopedic ligament and tendon surgeries. The clearance covers six additional EasyWhip® products across a range of suture sizes and needle geometries, including new curved variants.

EasyWhip® enables surgeons to create both traditional whip stitches and Winter Innovations' proprietary WhipLock™ stitch pattern with a single device. By offering additional suture sizes and needle configurations, the EasyWhip® Family is designed to meet a broader range of procedural needs and surgeon preferences across sports medicine, foot and ankle, and other orthopedic soft tissue procedures.

"This clearance is a major milestone for Winter Innovations and for the future of the EasyWhip® platform," said Lia Winter, CEO and co-founder of Winter Innovations. "We are especially proud to be at the forefront of regulatory strategy with authorization of a Predetermined Change Control Plan (PCCP), which we believe is the first in our device category. With fewer than 150 PCCPs authorized to date, this milestone reflects the strength of our team and creates an efficient path to expand the EasyWhip® Family."

As part of the clearance, FDA also authorized a Predetermined Change Control Plan (PCCP) for the EasyWhip® Family. The PCCP allows Winter Innovations to implement pre-specified product modifications, including expanded suture sizes and color configurations, without needing to submit a new 510(k). The PCCP creates a predictable pathway for future product line expansion while supporting the company's broader commercialization strategy.

"The EasyWhip® Family represents an important step in expanding the clinical and commercial potential of our technology," said Preston Dishner, COO and co-founder of Winter Innovations. "Surgeons have asked for more options, and this clearance allows us to offer a portfolio while continuing to build on the simplicity, versatility, and performance that have driven early adoption of EasyWhip®. We believe this expanded family creates a strong foundation for rapid growth as we work to bring EasyWhip® to more surgeons, facilities, and patients."

Following FDA clearance, Winter Innovations plans to initiate a limited U.S. commercial release of the expanded EasyWhip® Family, beginning with select surgeon users and facilities while preparing for broader commercial expansion.

About Winter Innovations

Winter Innovations is an award-winning medical device company dedicated to developing simple, impactful tools that address unmet needs in orthopedic soft tissue surgery. Its flagship product, EasyWhip®, is a patented two-part needle system that simplifies stitching, enhances biomechanical security, and improves efficiency in ligament and tendon surgeries. Winter Innovations has secured multiple research grants, prizes in national pitch competitions, and placements in top-tier accelerator programs. Building on strong early clinical adoption, the company is expanding the EasyWhip® product family and accelerating commercialization to improve surgical outcomes at scale.

Media Contact

Lia Winter, MS, MBA – CEO
Email: lia.winter@winter-innovations.com
Website: www.winter-innovations.com