FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AETOS Shoulder System Stemless Humeral Prosthesis
K Number: K252129
·
Decision Oct 3, 2025
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
18
Applicant Total
529
Review Days
88
Basic Information
- Device Name
- AETOS Shoulder System Stemless Humeral Prosthesis
- K Number
- K252129
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew, Inc.
- Date Received
- July 7, 2025
- Decision Date
- October 3, 2025
- Product Code
- PKC
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | FDA class 2 | Orthopedic |
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