Medical Device Development Partnership Leads to FDA Milestone for Spring Distraction System™

Medical Device Development

Partnerships are essential for bringing innovative healthcare solutions to patients. At BAAT Medical, we are proud to celebrate a major milestone with Cresco Spine. Recently, the first patient in the United States received treatment with the FDA-cleared Spring Distraction System™ (SDS™). As the Legal Manufacturer, BAAT Medical supported the product from development through regulatory approval and commercialization.

A Partnership Built on Innovation

Strong partnerships help create better medical devices. From the beginning, BAAT Medical and Cresco Spine worked together to improve the Spring Distraction System™. Together, both teams combined engineering expertise, regulatory knowledge, and clinical insights. As a result, they developed a solution that supports children with early-onset scoliosis. Through this close collaboration, the teams were able to address development challenges while keeping patient needs at the center of the project.

Solving an Engineering Challenge

During development, the team identified wear at one of the device’s connection points. Although this issue had not caused clinical problems, both teams decided to improve the design before moving forward. Therefore, BAAT Medical and Cresco Spine developed the proprietary Axial Sliding Bearing. The bearing uses a polyethylene liner to eliminate metal-on-metal contact. As a result, it reduces wear while allowing the system to move smoothly. In addition, the engineers introduced a C-clamp. This design gives surgeons more flexibility during treatment and further supports the practical use of the system.

BAAT Medical as Legal Manufacturer

BAAT Medical serves as the Legal Manufacturer of the Spring Distraction System™. Throughout the project, our team worked closely with Cresco Spine on product development, quality management, and regulatory activities.
Furthermore, our specialists supported Design Control, Risk Management, Verification and Validation (V&V), technical documentation, and regulatory submissions. Because these activities were closely integrated, the project could move efficiently from concept to market. Here you can learn more about these services and solutions for you.

Achieving Important Regulatory Milestones

The collaboration reached several significant milestones. First, the Spring Distraction System™ received FDA Breakthrough Device Designation in 2023. Next, the device achieved FDA 510(k) Clearance in January 2026. Meanwhile, BAAT Medical and Cresco Spine continue to work toward CE marking for the European market. Together, these achievements demonstrate the importance of combining innovative engineering with strong regulatory expertise.

Making a Difference for Patients

The greatest milestone came when the first patient in the United States received the FDA-cleared Spring Distraction System™. The procedure took place at Scottish Rite for Children and treated a young patient with neuromuscular scoliosis. Today, the technology developed through this Medical Device Development Partnership is helping improve patient care. Ultimately, this achievement reflects years of dedication, collaboration, and innovation from everyone involved.

Supporting MedTech Innovation Worldwide

At BAAT Medical, we help MedTech companies transform innovative ideas into safe and compliant medical devices. As a Legal Manufacturer, we can provide support throughout the entire product lifecycle. However, we can also support our partners with specific development, regulatory, quality, or manufacturing activities.

Our expertise includes:

• Medical Device Development
• Legal Manufacturer services
• Design Control
• ISO 13485 Quality Management
• Risk Management
• Verification & Validation (V&V)
• FDA and CE MDR Regulatory Affairs
• Manufacturing Transfer
• Medical Device Distribution

Finally, we congratulate Cresco Spine on this outstanding achievement. We look forward to continuing our collaboration and helping bring innovative medical devices to patients around the world. Interested in partnering with BAAT Medical? Explore our Medical Device Development services or contact our team to discuss your next innovation.