Chest Wall Innovations, Inc. - FDA 510(k) Cleared Devices

Chest Wall Innovations, Inc. is a medical device company specializing in precision-engineered fixation systems for chest wall surgery. The company develops purpose-built technologies designed to enhance surgical accuracy, reduce complications, and support faster patient recovery. With a manufacturing facility in Hershey, US, the company focuses exclusively on advancing the surgical treatment of the chest wall through innovative biomechanical solutions.

The company has received 1 FDA 510(k) clearance from 1 total submission. Chest Wall Innovations operates in the Orthopedic device category, which represents 100% of its regulatory submissions. The company achieved its first clearance in 2026 and remains active, with recent FDA 510(k) activity confirming ongoing product development and market engagement.

The company's cleared device portfolio includes thoracic fixation systems engineered for chest wall reconstruction and stabilization. These solutions integrate modern materials and surgeon-focused design to support intraoperative precision and clinical outcomes.

For detailed information on cleared device names, product codes, and clearance dates, explore the full regulatory record in the 510(k) database.

510(k) submissions have been managed by Sagemar Medical, LLC as regulatory consultant.