FDA product code MDI: Prosthesis, Rib Replacement
MDI is the FDA product code for prosthesis, rib replacement. It is a Class II device, regulated under 21 CFR 888.3070 and reviewed by the Orthopedic panel. FDA has cleared 2 510(k) submissions under MDI, 1 in the last five years, from 2 different applicants. The average 510(k) review took 90 days (median 90); 115 days on average over the last three years. FDA has posted 1 recall for MDI devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Rib Replacement |
| Device class | Class II |
| Regulation | 21 CFR 888.3070 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MDI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 115 |
Compare with all 510(k) review times · Search every MDI clearance
Top MDI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| OrthoPediatrics Corp. | 1 | 2024-01-20 |
| Depuy Synthes Spine, Inc. | 1 | 2014-11-18 |
Most recent MDI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233105 | OrthoPediatrics Corp. | RESPONSE Rib and Pelvic System | 2024-01-20 | 115 |
| K142587 | Depuy Synthes Spine, Inc. | Vertical Expandable Prosthetic Titanium Rib | 2014-11-18 | 64 |
Recalls for MDI devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-07-29.
Frequently asked questions
What is FDA product code MDI?
MDI is the FDA product code for prosthesis, rib replacement. It is a Class II device, regulated under 21 CFR 888.3070 and reviewed by the Orthopedic panel.
What device class is MDI?
Class II, regulation 21 CFR 888.3070. Typical premarket route: 510(k).
How long does a 510(k) take for product code MDI?
Across 2 cleared submissions the average was 90 days from receipt to decision (median 90).
Which companies have the most MDI clearances?
OrthoPediatrics Corp. (1); Depuy Synthes Spine, Inc. (1).
Have MDI devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-07-29.
Next steps
- Run an FDA pathway report with predicate devices for product code MDI
- Run a recall and safety report across every MDI manufacturer
- Watch product code MDI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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