Pontis Orthopaedics, LLC

Pontis Orthopaedics, LLC specialises in orthopaedic devices focused on tendon and ligament repair. Their core products include metallic, multifilament sutures—such as stainless steel sutures with crimps—and reusable orthopaedic trocar blades. They also develop single-use suturing units and non-bioabsorbable tendon/ligament bone anchors. Examples include systems for flexor tendon repair, Achilles tendon repair, and crimp-based implants, all designed to enhance surgical fixation and healing.

Pontis Orthopaedics, LLC is based in the United States. Their devices are intended for use within the US market, where they comply with applicable medical device authorisation requirements. The company’s products are tailored for surgical applications in orthopaedics, particularly for tendon and ligament repair procedures.

Pontis Orthopaedics’ devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The 510(k) pathway is used for Class II devices to demonstrate substantial equivalence to a predicate device, while the UDI system ensures traceability and transparency in the supply chain. Both registries are critical for tracking and authorising medical devices in the US.

Pontis Orthopaedics’ devices are classified as Class II under FDA regulations. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness. Class II devices typically require pre-market notification (510(k)) to demonstrate they are substantially equivalent to a legally marketed predicate device before being authorised for use.