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MDIClass II

Prosthesis, Rib Replacement

21 CFR 888.3070 / Orthopedic
FDA source (opens on fda.gov)

MDI is the FDA product code for Prosthesis, Rib Replacement, a class II device type, regulated under 21 CFR 888.3070. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
MDI
Device name
Prosthesis, Rib Replacement
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.
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
1

Clearances, product code MDI

By decision year
2 clearances under product code MDI with a decision year between 2014 and 2024, 2014 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MDI by decision year
YearClearances
20141
20241

Applicants with the most clearances

Product code MDI
Applicants holding the most 510(k) clearances under product code MDI
ApplicantClearances
Depuy Synthes Spine1
Orthopediatrics Corp1

Companies listing this code with FDA

Companies whose registered establishments list this code