MDI — Prosthesis, Rib Replacement Class II

FDA Device Classification

Classification Details

Product Code
MDI
Device Class
Class II
Regulation Number
888.3070
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233105orthopediatricsRESPONSE™ Rib and Pelvic SystemJanuary 20, 2024
K142587depuy synthes spineVertical Expandable Prosthetic Titanium RibNovember 18, 2014