FDA product code MJT: Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented
MJT is the FDA product code for prosthesis, shoulder, humeral (bipolar hemi-shoulder) metal/polymer, cemented or uncemented. It is a Class III device, reviewed by the Orthopedic panel. FDA has cleared 3 510(k) submissions under MJT, from 3 different applicants. The average 510(k) review took 273 days (median 290).
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
| Implant | Yes |
Compare with all 510(k) review times · Search every MJT clearance
Top MJT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Howmedica Osteonics Corp. | 1 | 1999-07-20 |
| Endotec, Inc. | 1 | 1999-04-29 |
| Biomet, Inc. | 1 | 1997-02-18 |
Most recent MJT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K990712 | Howmedica Osteonics Corp. | OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM | 1999-07-20 | 138 |
| K982418 | Endotec, Inc. | BUECHEL-PAPPAS MODULAR SALVAGE STEM | 1999-04-29 | 290 |
| K960363 | Biomet, Inc. | BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143 | 1997-02-18 | 390 |
Recalls for MJT devices
openFDA lists no recalls for product code MJT.
Frequently asked questions
What is FDA product code MJT?
MJT is the FDA product code for prosthesis, shoulder, humeral (bipolar hemi-shoulder) metal/polymer, cemented or uncemented. It is a Class III device, reviewed by the Orthopedic panel.
What device class is MJT?
Class III. Typical premarket route: Contact FDA.
How long does a 510(k) take for product code MJT?
Across 3 cleared submissions the average was 273 days from receipt to decision (median 290).
Which companies have the most MJT clearances?
Howmedica Osteonics Corp. (1); Endotec, Inc. (1); Biomet, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MJT
- Run a recall and safety report across every MJT manufacturer
- Watch product code MJT 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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