Prosthesis, Rib Replacement
The expandable rib prosthesis is an orthopedic implant used in children with or at risk of Thoracic Insufficiency Syndrome to mechanically stabilize or correct thoracic deformities, allowing the chest and lungs to grow normally; the device attaches perpendicularly to the patient's natural ribs and lumbar vertebrae. It is classified as FDA Class II under 21 CFR 888.3070 within the Orthopedic specialty, requiring 510(k) premarket clearance. The product code is MDI and it carries an implant flag reflecting its surgical placement. Full GMP compliance is required.
Research product code MDI in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- MDI
- Device Class
- FDA class 2
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.