Identity
- Trade Name
- U2 Total Knee System EUDAMEDFDA UDI
- Generic Name
- Cruciate-retaining total knee prosthesis FDA UDI
- Device Name
- U2 Total Knee System E-XPE Tibial Insert, Ultracongruent, #7, 17mm Thick EUDAMEDE-XPE Tibial insert, UC, #7, 17mm FDA UDI
- Model / Reference
- 2303-1770 EUDAMEDFDA UDI
- Description
- E-XPE Tibial insert, UC, #7, 17mm FDA UDI
Identifiers
- Catalog Number
- 2303-1770 FDA UDI
- Primary DI / UDI-DI
- 04719872150695 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04719872150695 EUDAMED
- 510(k) Number
- K161705 FDA UDI
- FDA Product Code
- JWH FDA UDIMBH FDA UDIOIY FDA UDI
- EMDN Code
- P090903020202 BICOMPARTMENTAL PRIMARY IMPLANT FIXED BEARING TIBIAL INSERTS EUDAMED
- GMDN Term
- Cruciate-retaining total knee prosthesis FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3560 FDA UDI888.3565 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Posterior-stabilized total knee prosthesisCruciate-retaining total knee prosthesis
U2 Total Knee System by United Orthopedic Corp. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cruciate-retaining total knee prosthesis.
- Arthrex® — Arthrex, Inc. · Class II
- Columbus® UC — AESCULAP, INC. · Class II
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC · Class II
- B-P TOTAL KNEE SYSTEM — ENDOTEC, INC. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
Cleared under the same submission
K161705 also covers:
- E-XPE Tibial insert, PS — UNITED ORTHOPEDIC CORP.
- E-XPE Tibial insert, PS — UNITED ORTHOPEDIC CORP.
- E-XPE Tibial insert, PS — UNITED ORTHOPEDIC CORP.
- E-XPE Tibial insert, PS — UNITED ORTHOPEDIC CORP.
- E-XPE Tibial insert, PS — UNITED ORTHOPEDIC CORP.
- E-XPE Tibial insert, PSA — UNITED ORTHOPEDIC CORP.
- E-XPE Tibial insert, PSA — UNITED ORTHOPEDIC CORP.
- E-XPE Tibial insert, PSA — UNITED ORTHOPEDIC CORP.
- E-XPE Tibial insert, PSA — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- United Orthopedic Corp.
Sources (2)
- FDA UDI 9c1196b3-6294-4bda-8dff-e3e160209686 37 fields · synced Oct 5, 2026
- EUDAMED daec05f0-38da-45a2-b5af-726503f2cfae 61 fields · synced Oct 5, 2026