Identity
- Trade Name
- USTAR II Knee System EUDAMED"UNITED" USTAR II Knee System FDA UDI
- Generic Name
- Rotating hinged total knee prosthesis FDA UDI
- Device Name
- USTAR II Knee System XPE Tibial Insert, S, 30mm EUDAMEDXPE Tibial insert, S, 30mm FDA UDI
- Model / Reference
- 2315-3217 EUDAMEDFDA UDI
- Description
- XPE Tibial insert, S, 30mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04711605580366 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04711605580366 EUDAMED
- 510(k) Number
- K190100 FDA UDI
- FDA Product Code
- KWL FDA UDILWJ FDA UDILPH FDA UDIKRO FDA UDI
- EMDN Code
- P090906 KNEE PROSTHESES FOR LARGE RESECTIONS EUDAMED
- GMDN Term
- Rotating hinged total knee prosthesis FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3360 FDA UDI888.3358 FDA UDI888.3510 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
USTAR II Knee System by United Orthopedic Corporation — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-04711605580366 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | 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 08d5cf86-8892-478f-96d0-6d544d594cf8 61 fields · synced Jun 9, 2026
- FDA UDI eccf958c-7c41-497f-920d-edbcae832d4c 35 fields · synced May 30, 2026