FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants
K Number: K250713
·
Decision Dec 1, 2025
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
70
Applicant Total
186
Review Days
266
Basic Information
- Device Name
- Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants
- K Number
- K250713
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3650
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Exactech, Inc.
- Date Received
- March 10, 2025
- Decision Date
- December 1, 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 Exactech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260583 | Equinoxe® Shoulder System | Apr 14, 2026 | Substantially Equivalent |
| K243448 | Equinoxe® Shoulder System | Aug 1, 2025 | Substantially Equivalent |
| K243275 | Equinoxe® Scapula Fracture System | Jun 26, 2025 | Substantially Equivalent |
| K243839 | Alteon® HA Femoral Stems | Mar 10, 2025 | Substantially Equivalent |
| K240393 | Exactech® TRULIANT® Knee System | Oct 3, 2024 | Substantially Equivalent |
| K233482 | Equinoxe® Central Screw Baseplate System | Jul 18, 2024 | Substantially Equivalent |
| K230717 | Exactech® Vantage® Total Ankle System | Oct 12, 2023 | Substantially Equivalent |
| K223933 | Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws | Sep 25, 2023 | Substantially Equivalent |
| K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays | Sep 14, 2023 | Substantially Equivalent |
| K232002 | Vantage® Total Ankle System | Sep 11, 2023 | Substantially Equivalent |