We have helped our clients meet FDA and other international regulatory requirements and conduct clinical studies for over 130 orthopedic device projects. Our experience includes all types of orthopedic devices and instrumentation, 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
- Joint injection therapies – full service clinical trial management
- Bone growth factors – full service clinical trial management
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. Aptiv Solutions 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 our guidance, the company was able to receive clearance for its orthopedic device and and its market to the United States.
Contact us to learn more about orthopedic device compliance.
