Identity
- Trade Name
- U2 Total Knee System FDA UDI
- Generic Name
- Knee femur prosthesis trial, reusable FDA UDI
- Device Name
- Femoral distal augment trial, left medial/right lateral, #1, 16mm FDA UDI
- Model / Reference
- 2623-6114 FDA UDI
- Description
- Femoral distal augment trial, left medial/right lateral, #1, 16mm FDA UDI
Identifiers
- Catalog Number
- 2623-6114 FDA UDI
- Primary DI / UDI-DI
- 04719886907360 FDA UDI
- 510(k) Number
- K122183 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Knee femur prosthesis trial, reusable 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Knee femur prosthesis trial, reusable
U2 Total Knee System by United Orthopedic Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Knee femur prosthesis trial, reusable.
- Lospa Modular Knee System — Corentec Co., Ltd · Class II
- OSS™ — Biomet Orthopedics, Inc. · Class II
- VANGUARD 360 INSTRUMENT — Biomet Orthopedics, Inc. · Class II
- VANGUARD(TM) PS FEMORAL TRIAL — Biomet Orthopedics, Inc. · Class II
- Natural-Knee® — Zimmer, Inc. · Class II
- NexGen® — Zimmer, Inc. · Class II
- LOSPA Knee System — Corentec Co., Ltd · Class II
- Persona® — Zimmer, Inc. · Class II
Cleared under the same submission
K122183 also covers:
- Femoral augment, distal only — UNITED ORTHOPEDIC CORP.
- Femoral augment, distal only — UNITED ORTHOPEDIC CORP.
- Tibial augment, screw locking — UNITED ORTHOPEDIC CORP.
- U2 Total Knee System — UNITED ORTHOPEDIC CORP.
- U2 Total Knee System — UNITED ORTHOPEDIC CORP.
- U2 Total Knee System — UNITED ORTHOPEDIC CORP.
- U2 Total Knee System — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — 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 8c22b57b-881b-426e-9dbe-b7311655f17a 36 fields · synced May 30, 2026