FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Klassic Knee Revision System
K Number: K230537
·
Decision May 19, 2023
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
8
Review Days
81
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Basic Information
- Device Name
- Klassic Knee Revision System
- K Number
- K230537
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Total Joint Othopedics, Inc.
- Date Received
- February 27, 2023
- Decision Date
- May 19, 2023
- Product Code
- JWH
- 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 |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
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Other Clearances by Total Joint Othopedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243991 | Klassic Knee System - Revision Tibial Baseplate | Mar 24, 2025 | Substantially Equivalent |
| K232414 | Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post | Sep 8, 2023 | Substantially Equivalent |
| K213580 | Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length | Dec 3, 2021 | Substantially Equivalent |
| K191399 | BIOLOX CONTOURA Ceramic Femoral Head | Aug 28, 2019 | Substantially Equivalent |
| K171962 | Klassic HD® Hip System | Jul 24, 2017 | Substantially Equivalent |
| K161073 | Klassic HD Hip System | Oct 19, 2016 | Substantially Equivalent |
| K143407 | Klassic HD Hip System | Dec 23, 2014 | Substantially Equivalent |