FDA Product Code MDI: Prosthesis, Rib Replacement
In Children With Or At Risk Of Developing Thoracic Insufficiency Syndrome, The Expandable Rib Prosthesis Devices Mechanically Stabilize And/or Correct Thoracic Deformities To Allow The Chest And Lungs To Grow. The Devices Are Attached Perpendicularly To The Subject's Natural Ribs And Lumbar Vertebra Or Pelvis. This Mechanically Stabilizes The Chest Wall And Enlarges The Thorax To Improve Respiration And Lung Growth. The Devices Allow Assembly In A Number Of Different Configurations To Accommodate The Wide Variety Of Anatomical Deformities Encountered By The Clinician In Treating Patients With Or At Risk Of Developing Thoracic Insufficiency Syndrome.
Leading manufacturers include OrthoPediatrics Corp..
List of Prosthesis, Rib Replacement devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Prosthesis, Rib Replacement devices (product code MDI). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →