FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Arthrex Eclipse Titanium Humeral Head
K Number: K203100
·
Decision Nov 20, 2020
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
18
Applicant Total
348
Review Days
37
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Arthrex Eclipse Titanium Humeral Head
- K Number
- K203100
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arthrex, Inc.
- Date Received
- October 14, 2020
- Decision Date
- November 20, 2020
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PKC), ordered by most recent decision date.
FX V135 EASYTECH® Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
AETOS Shoulder System Stemless Humeral Prosthesis
FDA 510(k)
FDA Class 2
·Orthopedic
INHANCE INTACT
FDA 510(k)
FDA Class 2
·Orthopedic
OsseoFit Stemless Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
AETOS Shoulder System Stemless Humeral Prosthesis
FDA 510(k)
FDA Class 2
·Orthopedic
SMR Stemless Anatomic
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Arthrex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253931 | Arthrex Bioabsorbable PushLock Suture Anchors | May 28, 2026 | Substantially Equivalent |
| K254215 | Arthrex Beaming System | May 8, 2026 | Substantially Equivalent |
| K252016 | Arthrex Humeral Nails | Mar 20, 2026 | Substantially Equivalent |
| K260561 | Arthrex FiberTak Suture Anchor | Mar 20, 2026 | Substantially Equivalent |
| K260405 | FiberTape Button | Mar 9, 2026 | Substantially Equivalent |
| K252196 | Arthrex FibuLock Nail System | Mar 5, 2026 | Substantially Equivalent |
| K260353 | Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | Mar 3, 2026 | Substantially Equivalent |
| K254229 | Arthrex Nano FiberTak Suture Anchor | Mar 2, 2026 | Substantially Equivalent |
| K253713 | Arthrex Variable Angle (VA) Proximal Tibia Plating System | Jan 21, 2026 | Substantially Equivalent |
| K252807 | Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates | Jan 12, 2026 | Substantially Equivalent |