FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER
K Number: K131116
·
Decision Oct 30, 2013
Classifications
1
FEI Numbers
320
Registration Numbers
320
Same Product Code
902
Applicant Total
21
Review Days
191
Basic Information
- Device Name
- U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER
- K Number
- K131116
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- UNITED ORTHOPEDIC CORPORATION
- Date Received
- April 22, 2013
- Decision Date
- October 30, 2013
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JWH), ordered by most recent decision date.
EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert)
FDA 510(k)
FDA Class 2
·Orthopedic
EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones)
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom® Total Knee System Titanium Tibial Base Plate
FDA 510(k)
FDA Class 2
·Orthopedic
NextStep Arthropedix Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
EXULT Knee Replacement System
FDA 510(k)
FDA Class 2
·Orthopedic
LEGION Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by UNITED ORTHOPEDIC CORPORATION
| K Number | Device Name | ||
|---|---|---|---|
| K163441 | Locking Cage, Full XPE Cup | Aug 25, 2017 | Substantially Equivalent |
| K162957 | U2 Femoral Head | Jul 17, 2017 | Substantially Equivalent |
| K163193 | UTF Stem, reduced, #0, #00 | Jun 8, 2017 | Substantially Equivalent |
| K161705 | U2 Total Knee System E-XPE products | Mar 16, 2017 | Substantially Equivalent |
| K161360 | U2 Total Knee System, PSA Tibial Insert | Feb 1, 2017 | Substantially Equivalent |
| K152430 | All Poly Tibial Component | Apr 12, 2016 | Substantially Equivalent |
| K152439 | U2 Bipolar Implant and 22mm Femoral Head | Apr 7, 2016 | Substantially Equivalent |
| K152530 | UCP Stem | Mar 14, 2016 | Substantially Equivalent |
| K150832 | U2 Femoral Component, CR, Porous Coated, Additional Sizes | Sep 25, 2015 | Substantially Equivalent |
| K150829 | U2 Total Knee System- Additional Sizes | Sep 25, 2015 | Substantially Equivalent |