ARCURO MEDICAL LTD

Arcuro Medical Ltd specializes in polyester-based, non-bioabsorbable, multifilament sutures. These are primarily used for soft tissue and meniscal repair in orthopedic applications. Their product line includes fixed-angle and adjustable suture anchors, as well as specialized meniscal repair systems, all designed to provide secure fixation in surgical procedures.

Arcuro Medical Ltd is headquartered in the United States. The company’s location is relevant for understanding its regulatory oversight and compliance with U.S. medical device regulations.

Arcuro Medical Ltd’s devices fall under Class II classification according to FDA regulations. This classification is typically assigned to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as suture anchors and meniscal repair systems.

Arcuro Medical Ltd’s devices are included in the FDA’s 510(k) database and the FDA’s Unique Device Identifier (UDI) system. These registries track premarket submissions and device identification for traceability and compliance purposes, ensuring transparency in the medical device supply chain.

The Class II classification for Arcuro Medical Ltd’s suture anchors and meniscal repair systems is due to their intended use in orthopedic procedures where they provide structural support or fixation. While these devices are not invasive like Class III implants, they require validation of performance, labeling controls, and post-market surveillance to mitigate risks such as improper fixation or tissue damage, justifying the higher regulatory scrutiny of Class II.