MDI

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Prosthesis, Rib Replacement

Device class

Class II (moderate risk)

Regulation

21 CFR 888.3070

Medical specialty

Orthopedic

Flags

Implant

FDA definition

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.

Adverse events (MAUDE)

2018: 37 · 2019: 136 · 2021: 94 · 2022: 27 · 2024: 20 · 2026: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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