Identity
- Trade Name
- USTAR II Hip System EUDAMED"UNITED" USTAR II Hip System FDA UDI
- Generic Name
- Metal-on-polyethylene total hip prosthesis FDA UDI
- Device Name
- USTAR II Hip System Press-Fit Curved Stem, RHS, Ti Plasma Spray, 13mm Dia., 150mm Stem Length EUDAMEDPress-Fit Curved Stem, RHS Ti plasma Spray Ø13×150mm FDA UDI
- Model / Reference
- 1115-1213 EUDAMEDFDA UDI
- Description
- Press-Fit Curved Stem, RHS Ti plasma Spray Ø13×150mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719872153863 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04719872153863 EUDAMED
- 510(k) Number
- K190100 FDA UDI
- FDA Product Code
- KRO FDA UDILPH FDA UDILWJ FDA UDIKWL FDA UDI
- EMDN Code
- P09080404 LARGE RESECTIONS FEMORAL STEMS EUDAMED
- GMDN Term
- Metal-on-polyethylene total hip prosthesis FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3510 FDA UDI888.3358 FDA UDI888.3360 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 Hip 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-04719872153863 | 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 ee21ce02-86b9-4c90-8737-716d45b5efb3 61 fields · synced Jul 30, 2026
- FDA UDI 050337fa-e201-454c-ab64-22180d388419 35 fields · synced May 30, 2026