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Orthopedic Medical Devices

MDCI has assisted clients in meeting FDA and other international regulatory requirements for numerous orthopedic devices including:

• Hip and knee implants – IDE submission, clinical study design and development, 510(k) submission
• Spinal fusion implants– IDE submission, clinical study design and development, 510(k) submission
• Surgical instrumentation– IDE submission, clinical study design and development, 510(k) submission
• Fracture fixation devices– IDE submission, clinical study design and development, 510(k) submission
• Reconstructive joint devices– IDE submission, clinical study design and development, 510(k) submission
• Spinal fixation devices– IDE submission, clinical study design and development, 510(k) submission
• Bone matrix devices– IDE submission, clinical study design and development, 510(k) submission
• Stem cells for spinal fusion – clinical trial monitoring, data management, and Data and Safety Monitoring Board (DSMB) management

Orthopedic Medical Device Case Study

Approximately 50 million people in the United States suffer from back pain. In 2004, more than 1 million spine surgeries were performed in the U.S. One of the most common spine surgeries, spinal fusion, accounts for an estimated 380,000 procedures in the U.S. and fuels a market estimated at more than $2.3 billion.

A small European start-up company developed its first product, a spinal vertebral body replacement device (VBR) intended for use as an aid in spinal fusion. The company, who had successfully CE marked the device and was actively selling in Europe, now looked to expand into the growing U.S. market, but had very little experience with the FDA regulatory process. They had written a draft 510(k) for submission to the FDA, but sought an expert and critical review of their document, to ensure that it would successfully fulfill all the relevant FDA requirements. MDCI reviewed the submission, made suggestions for improvement based on our experience with FDA’s requirements for spinal systems, and served as the company’s liaison throughout the 510(k) review and negotiation process. With MDCI’s guidance, the company was able to receive clearance for its orthopedic device and expand its market to the United States.

Contact us to learn more about orthopedic device compliance.