FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
InSet Total Shoulder System
K Number: K241817
·
Decision Feb 11, 2025
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
70
Applicant Total
8
Review Days
232
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Basic Information
- Device Name
- InSet Total Shoulder System
- K Number
- K241817
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3650
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shoulder Innovations, Inc.
- Date Received
- June 24, 2024
- Decision Date
- February 11, 2025
- Product Code
- KWT
- 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 |
|---|---|---|---|
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | FDA class 2 | Orthopedic |
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Other Clearances by Shoulder Innovations, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K254128 | InSet Reverse Total Shoulder System | Apr 13, 2026 | Substantially Equivalent |
| K252516 | N22 EZ Glenosphere | Jan 15, 2026 | Substantially Equivalent |
| K252221 | Inset Reverse Total Shoulder System | Sep 26, 2025 | Substantially Equivalent |
| K213615 | Shoulder Innovations Total Shoulder System | Mar 11, 2022 | Substantially Equivalent |
| K210533 | Inset Reverse Total Shoulder System | Aug 20, 2021 | Substantially Equivalent |
| K192365 | Shoulder Innovations Total Shoulder System | Nov 29, 2019 | Substantially Equivalent |
| K173824 | Humeral Short Stem System | Oct 23, 2018 | Substantially Equivalent |