Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
The Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented is a total shoulder replacement implant for use in patients with arthritis (osteoarthritis, rheumatoid arthritis, or traumatic arthritis), avascular necrosis, correction of functional deformity, and revision procedures. It falls under the Orthopedic medical specialty and is regulated as a Class 2 device under regulation 888.3660, requiring 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. As an implanted device, it is subject to general controls and special controls; it is not considered life-sustaining.
Research product code PAO 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
- PAO
- Device Class
- FDA class 2
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
Definition
Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K201315 | PERFORM Humeral System Stem | Sep 11, 2020 | Substantially Equivalent | Tornier, Inc. |
FEI Numbers
This FDA classification entry is associated with 69 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 69 registration numbers. Click on an entry to view related FDA registrations.