FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
U2 Total Knee System, XPE Tibial Insert, PS PLUS
K Number: K210961
·
Decision Apr 21, 2021
Classifications
1
FEI Numbers
320
Registration Numbers
320
Same Product Code
902
Applicant Total
16
Review Days
21
Basic Information
- Device Name
- U2 Total Knee System, XPE Tibial Insert, PS PLUS
- K Number
- K210961
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- United Orthopedic Corporation
- Date Received
- March 31, 2021
- Decision Date
- April 21, 2021
- 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 United Orthopedic Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K242315 | Resolve Modular Revision Hip Stem | May 1, 2025 | Substantially Equivalent |
| K243466 | Conformity Stem Extension Line, #0 | Jan 6, 2025 | Substantially Equivalent |
| K243024 | Cellbrick Knee Spacer | Dec 20, 2024 | Substantially Equivalent |
| K242249 | Conformity Stem Extension Line | Aug 30, 2024 | Substantially Equivalent |
| K221705 | U2 Total Knee System-PF+ | Feb 28, 2023 | Substantially Equivalent |
| K221149 | U-Motion II Acetabular System-Extension line | Jan 5, 2023 | Substantially Equivalent |
| K221675 | United U2 femoral head, 22mm delta ceramic head | Nov 4, 2022 | Substantially Equivalent |
| K222700 | Tibial baseplate, Tibial insert | Oct 6, 2022 | Substantially Equivalent |
| K191056 | Conformity stem, cemented | Jan 3, 2020 | Substantially Equivalent |
| K190100 | USTAR II System | Sep 23, 2019 | Substantially Equivalent |