Guiding a Device Breakthrough Journey to U.S. Market Entry

Situation

Cresco Spine, a Dutch startup originating from the University Medical Center Utrecht, set out to develop the Cresco Spine SDS, also known as the Spring Distraction System™ (SDS™). The dynamic implant is intended to treat Early Onset Scoliosis (EOS). This severe pediatric spinal deformity often requires multiple invasive surgeries. The goal was to enable continuous, guided spinal growth while reducing the need for repeated lengthening interventions. Ultimately, Cresco aimed to bring this innovation to international markets.

Capabilities

Instead of building internal development and manufacturing capabilities, Cresco chose to partner with an experienced external organization. The company required support to mature the implant design and validate manufacturing processes. It also needed a certified Quality Management System (QMS) and a manufacturer of record. This approach allowed Cresco to focus on clinical engagement and market strategy. At the same time, BAAT addressed the technical challenges of developing a dynamic, spring-based spinal system.

Solution

BAAT transferred all prior development work into its own QMS. The team identified the remaining gaps and advanced the project through its development process. In parallel, BAAT aligned the technical and regulatory requirements for U.S. and European pathways. This provided a structured approach for the further development of the Cresco Spine SDS. Recognizing the potential of the device for treating EOS, BAAT guided Cresco in obtaining FDA Breakthrough Device Designation. Following this designation, BAAT optimized the testing and documentation strategy for a 510(k) submission. In parallel, BAAT supported Cresco in preparing the device for EU review under the Orphan Device framework.

Result

BAAT supported Cresco Spine through successful FDA 510(k) clearance for the Cresco Spine SDS in January 2026. This enabled entry into the U.S. market. As a result, Cresco could focus on clinical adoption and commercial growth while continuing its European regulatory activities. With Breakthrough Device Designation, FDA clearance and growing clinical evidence, the SDS™ continues to advance toward broader clinical adoption. The project demonstrates how an experienced medical device partner can support a startup from product development through regulatory clearance and market entry. By combining technical expertise, regulatory strategy and QMS capabilities, BAAT helped Cresco move its innovative spinal implant toward international markets.