CARTIHEAL (2009) LTD

CartiHeal (2009) Ltd specializes in orthopaedic medical devices. Their portfolio includes reusable, non-medicated surgical procedure kits for orthopaedic use, osteochondral matrix implants designed for joint repair, and single-use orthopaedic tools like implant inserters/extractors and specialized handles. These devices are tailored for procedures involving bone and cartilage, such as joint reconstruction or repair.

CartiHeal (2009) Ltd is headquartered in the United States. Their location influences regulatory compliance and distribution, particularly for devices authorized under U.S. frameworks like the FDA’s UDI system.

CartiHeal’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for authorized products, including orthopaedic surgical kits, osteochondral implants, and related tools. Listing in the UDI system is critical for compliance with U.S. medical device regulations.

CartiHeal’s devices fall into two regulatory classes: Class II and Class III. Class II devices typically pose moderate risk and require special controls beyond general controls, while Class III devices are higher risk (e.g., supporting life or posing significant risk of illness/injury) and require premarket approval. The classification determines the authorization pathway and scrutiny each device undergoes.

CartiHeal’s reusable orthopaedic surgical procedure kits are designed for multiple uses without medication, emphasizing durability and sterilization compatibility. In contrast, their single-use tools—like implant inserters/extractors or specialized handles—are intended for one-time use to ensure sterility and reduce cross-contamination risks. The distinction reflects procedural needs: reusable kits prioritize cost-efficiency for repeated procedures, while single-use tools prioritize safety for critical, one-off implant applications.