Identity
- Trade Name
- U2 Total Knee System EUDAMEDOffset stem adapter FDA UDI
- Generic Name
- Posterior-stabilized total knee prosthesis FDA UDI
- Device Name
- U2 Total Knee System Offset Stem Adapter, PSA, 6mm EUDAMEDOffset stem adapter, 6mm FDA UDI
- Model / Reference
- 2903-1030 EUDAMEDFDA UDI
- Description
- Offset stem adapter, 6mm FDA UDI
Identifiers
- Catalog Number
- 2903-1030 FDA UDI
- Primary DI / UDI-DI
- 04712602349734 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04712602349734 EUDAMED
- 510(k) Number
- K082424 FDA UDI
- FDA Product Code
- JWH FDA UDI
- EMDN Code
- P09098002 KNEE PROSTHESES ADAPTERS (INCLUDING CONES AND SLEEVES) EUDAMED
- GMDN Term
- Posterior-stabilized total knee prosthesis FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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: Knee arthroplasty wedge
U2 Total Knee System by United Orthopedic Corporation — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Knee arthroplasty wedge.
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- ADVANTIM® — MicroPort Orthopedics Inc. · Class II
- LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KG · Class II
- Unity Total Knee System — CORIN LTD · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04712602349734 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- United Orthopedic Corporation
- EUDAMED SRN
- TW-MF-000009523
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED 9415a5ea-bf64-492f-8fc0-e0b32caa4950 61 fields · synced Jul 14, 2026
- FDA UDI 44677646-3067-47af-b68e-99e04a3a1de7 37 fields · synced May 30, 2026