Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented
The Bipolar Hemi-Shoulder Prosthesis (Metal/Polymer, Cemented or Uncemented) is a partial shoulder replacement implant consisting of a humeral stem and a dual-articulation bipolar head component used to resurface the humeral side of the glenohumeral joint, typically in patients with proximal humeral fractures or avascular necrosis when glenoid replacement is not indicated. As a Class 3 implantable device, it requires Premarket Approval (PMA) given the high risks associated with load-bearing joint implants. It carries an implant flag, and no regulation number or medical specialty code is recorded.
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Basic Information
- Product Code
- MJT
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- OR
- Submission Type
- 3
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K990712 | OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM | Jul 20, 1999 | Substantially Equivalent | Howmedica Osteonics Corp. |
| K982418 | BUECHEL-PAPPAS MODULAR SALVAGE STEM | Apr 29, 1999 | Substantially Equivalent | Endotec, Inc. |
| K960363 | BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143 | Feb 18, 1997 | Substantially Equivalent | Biomet, Inc. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.