Identity
- Trade Name
- United Hip System, U-Motion II XPE Cup Liner FDA UDI
- Generic Name
- Ceramic-on-ceramic total hip prosthesis FDA UDI
- Device Name
- U-Motion II XPE Cup Liner, 0 DEG., I.D. 32mm, O.D. 76mm FDA UDI
- Model / Reference
- 1406-3276 FDA UDI
- Description
- U-Motion II XPE Cup Liner, 0 DEG., I.D. 32mm, O.D. 76mm FDA UDI
Identifiers
- Catalog Number
- 1406-3276 FDA UDI
- Primary DI / UDI-DI
- 04712771503746 FDA UDI
- 510(k) Number
- K122185 FDA UDI
- FDA Product Code
- LZO FDA UDIMEH FDA UDIKWY FDA UDILWJ FDA UDI
- GMDN Term
- Ceramic-on-ceramic total hip prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3390 FDA UDI888.3360 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 76 Millimeter FDA UDILumen/Inner Diameter — 32 Millimeter FDA UDIAngle — 0 degree FDA UDI
Category: Ceramic-on-polyethylene total hip prosthesisCeramic-on-ceramic total hip prosthesis
United Hip System, U-Motion II XPE Cup Liner by United Orthopedic Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ceramic-on-ceramic total hip prosthesis.
- Ceramic Femoral Head BIOLOX® Delta 12/14S — UNITED ORTHOPEDIC CORP. · Class II
- United Hip System, U-Motion II PS Cup, Multi-Hole — UNITED ORTHOPEDIC CORP. · Class II
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP. · Class II
- Ceramic Femoral Head BIOLOX® Delta 12/14XL — UNITED ORTHOPEDIC CORP. · Class II
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP. · Class II
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP. · Class II
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP. · Class II
- United Hip System, U-Motion II HA Cup, No-Hole — UNITED ORTHOPEDIC CORP. · Class II
Cleared under the same submission
K122185 also covers:
- Ceramic Femoral Head BIOLOX® Delta 12/14S — UNITED ORTHOPEDIC CORP.
- Ti Cancellous Screw — UNITED ORTHOPEDIC CORP.
- U-Motion II — UNITED ORTHOPEDIC CORP.
- U-Motion II — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP.
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- United Orthopedic Corp.
Sources (1)
- FDA UDI 1e574514-ec79-4930-bfe5-3f3df42c5e6c 37 fields · synced Jun 1, 2026