Ziptek, LLC

Ziptek, LLC specializes in devices for tendon and ligament repair, including bioabsorbable and non-bioabsorbable bone anchors. Their portfolio also covers reusable surgical tamp devices and non-torque-limiting surgical instrument handles, all designed for orthopaedic and soft tissue applications. The company’s most notable product line consists of knotless tissue repair and attachment devices, which eliminate the need for traditional knotting during surgery.

Ziptek, LLC is headquartered in the United States. The company’s devices are authorised for use in the US, where they are regulated under the FDA’s medical device classification system. The company’s regulatory submissions, including 510(k) clearances and Unique Device Identifier (UDI) listings, are publicly available in the FDA’s databases.

Ziptek, LLC’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries track submissions required for device authorisation in the United States, ensuring transparency about the company’s authorised products and their classification.

Ziptek, LLC’s devices fall into two primary FDA classification categories: Class I and Class II. Class I devices generally pose the lowest risk and may be exempt from some regulatory controls, while Class II devices require special controls to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with, such as tendons or ligaments.

Ziptek, LLC’s knotless tissue repair and attachment devices are designed to secure tendons and ligaments without the need for traditional knotting. This approach reduces surgical complexity, potentially lowers the risk of tissue irritation or damage from knots, and may shorten procedure time. The devices are engineered to provide secure fixation while minimising the need for manual knot-tying, aligning with modern trends toward less invasive and more efficient surgical techniques.