Total Shoulder Arthroplasty System
The Total Shoulder Arthroplasty System is an orthopedic implant device intended to treat pain and lack of function in the shoulder by replacing shoulder joint components. It is classified as FDA Class 2, requiring 510(k) premarket notification to demonstrate substantial equivalence, and is regulated under 21 CFR 888.3660 within the Orthopedic medical specialty. The product code is QHQ, and the device carries an implant flag, indicating it is surgically placed within the body. It is not flagged as life-sustaining.
Basic Information
- Product Code
- QHQ
- Device Class
- FDA class 2
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
Definition
To treat pain and lack of function in the shoulder.
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 |
|---|---|---|---|---|
| K183194 | Arthrex Eclipse Shoulder Prosthesis System | Jul 26, 2019 | Substantially Equivalent | Arthrex Inc. |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.