Identity
- Trade Name
- U2 Total Knee System FDA UDI
- Generic Name
- Knee femur prosthesis trial, reusable FDA UDI
- Device Name
- Tibial augment trial, #6, 5mm, left FDA UDI
- Model / Reference
- 2823-2161 FDA UDI
- Description
- Tibial augment trial, #6, 5mm, left FDA UDI
Identifiers
- Catalog Number
- 2823-2161 FDA UDI
- Primary DI / UDI-DI
- 04719886907858 FDA UDI
- 510(k) Number
- K190100 FDA UDI
- FDA Product Code
- KRO FDA UDILPH FDA UDILWJ FDA UDIKWL FDA UDI
- GMDN Term
- Knee femur prosthesis trial, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3510 FDA UDI888.3358 FDA UDI888.3360 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
A comprehensive solution for unicompartmental knee replacement surgery or total knee arthroplasty, providing accurate and precise alignment, size, and fit of the final prosthesis.
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
K190100 also covers:
- "UNITED" USTAR II Hip System — UNITED ORTHOPEDIC CORP.
- "UNITED" USTAR II Knee System — UNITED ORTHOPEDIC CORP.
- "UNITED" USTAR II 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 Total Knee System — UNITED ORTHOPEDIC CORP.
- U2 Total Knee System — UNITED ORTHOPEDIC CORP.
- USTAR II Knee System — UNITED ORTHOPEDIC CORP.
- USTAR II Knee System — UNITED ORTHOPEDIC CORP.
- USTAR II Knee System — UNITED ORTHOPEDIC CORP.
- USTAR II 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 |
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Manufacturer
- Manufacturer
- United Orthopedic Corp.
Sources (1)
- FDA UDI 7b9b70a2-fd7a-4338-ae65-bf75ca16a4fd 36 fields · synced Jul 24, 2026