MDI · Class II · 21 CFR 888.3070

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..

2
Total
2
Cleared
90d
Avg days
2014
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Prosthesis, Rib Replacement Devices (Product Code MDI)

2 devices
1–2 of 2
Cleared Jan 20, 2024
RESPONSE™ Rib and Pelvic System
K233105
OrthoPediatrics Corp.
Orthopedic · 115d

About Product Code MDI - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code MDI since 2014, with 2 receiving FDA clearance (average review time: 90 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

MDI devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →