Identity
- Trade Name
- U2 Tibial insert, PS FDA UDI
- Generic Name
- Posterior-stabilized total knee prosthesis FDA UDI
- Device Name
- U2 Tibial insert, PS, #5, 15mm FDA UDI
- Model / Reference
- 2303-3054 FDA UDI
- Description
- U2 Tibial insert, PS, #5, 15mm FDA UDI
Identifiers
- Catalog Number
- 2303-3054 FDA UDI
- Primary DI / UDI-DI
- 04712602348232 FDA UDI
- 510(k) Number
- K051640 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Posterior-stabilized total knee prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 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
Category: Posterior-stabilized total knee prosthesis
U2 Tibial insert, PS by United Orthopedic Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Posterior-stabilized total knee prosthesis.
- Evolution — MicroPort Orthopedics Inc. · Class II
- Evolution — MicroPort Orthopedics Inc. · Class II
- NovoKnee Total Knee System — Novosource, Inc. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- Evolution — MicroPort Orthopedics Inc. · Class II
- Evolution — MicroPort Orthopedics Inc. · Class II
- Consensus MBK System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
Cleared under the same submission
K051640 also covers:
- U2 Tibial insert, PS — UNITED ORTHOPEDIC CORP.
- U2 Tibial insert, PS — UNITED ORTHOPEDIC CORP.
- U2 Tibial insert, PS — UNITED ORTHOPEDIC CORP.
- U2 Tibial insert, PS — UNITED ORTHOPEDIC CORP.
- U2 Tibial insert, PS — UNITED ORTHOPEDIC CORP.
- U2 Tibial insert, PS — UNITED ORTHOPEDIC CORP.
- U2 Tibial insert, PS — UNITED ORTHOPEDIC CORP.
- U2 Tibial insert, PS — UNITED ORTHOPEDIC CORP.
- U2 Tibial insert, PS — UNITED ORTHOPEDIC CORP.
- U2 Tibial insert, PS — UNITED ORTHOPEDIC CORP.
- U2 Tibial insert, PS — UNITED ORTHOPEDIC CORP.
- U2 Total Knee System — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- United Orthopedic Corp.
Sources (1)
- FDA UDI a5815aaf-b150-4062-8344-82d0337a316b 37 fields · synced May 30, 2026