FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
United U2 femoral head, 22mm delta ceramic head
K Number: K221675
·
Decision Nov 4, 2022
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
40
Review Days
148
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- United U2 femoral head, 22mm delta ceramic head
- K Number
- K221675
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- United Orthopedic Corporation
- Date Received
- June 9, 2022
- Decision Date
- November 4, 2022
- Product Code
- LPH
- 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 |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LPH), ordered by most recent decision date.
iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating
FDA 510(k)
FDA Class 2
·Orthopedic
Taperloc® Complete Hip Stem
FDA 510(k)
FDA Class 2
·Orthopedic
G7® Revision Acetabular System
FDA 510(k)
FDA Class 2
·Orthopedic
Mpact 3D Metal Implants Extension DMLS Technology
FDA 510(k)
FDA Class 2
·Orthopedic
Velora Acetabular System
FDA 510(k)
FDA Class 2
·Orthopedic
TaperSet Hip System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by United Orthopedic Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K252725 | Stem Extension Line (U2 Total Knee SystemPSA Type) | Sep 25, 2025 | Substantially Equivalent |
| K252303 | Stem Extension Line (USTAR II System) | Aug 22, 2025 | Substantially Equivalent |
| K243656 | U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella | Jul 31, 2025 | Substantially Equivalent |
| 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 |
| K222700 | Tibial baseplate, Tibial insert | Oct 6, 2022 | Substantially Equivalent |