United Hip System, U2 Bipolar Implant
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- United Hip System EUDAMEDUnited Hip System, U2 Bipolar Implant FDA UDI
- Generic Name
- Bipolar femoral head outer component, hemiarthroplasty FDA UDI
- Device Name
- United Hip System U2 Bipolar Implant, 32mm I.D., 50mm O.D. EUDAMEDU2 Bipolar Implant, 32mm I.D., 50mm O.D. FDA UDI
- Model / Reference
- 1503-3250 EUDAMEDFDA UDI
- Description
- U2 Bipolar Implant, 32mm I.D., 50mm O.D. FDA UDI
Identifiers
- Catalog Number
- 1503-3250 FDA UDI
- Primary DI / UDI-DI
- 04712771494327 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04712771494327 EUDAMED
- 510(k) Number
- K101670 FDA UDI
- FDA Product Code
- KWY FDA UDI
- EMDN Code
- P090804050199 FEMORAL HEADS FOR PRIMARY IMPLANT OF PARTIAL PROSTHESES - OTHER EUDAMED
- GMDN Term
- Bipolar femoral head outer component, hemiarthroplasty FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3390 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
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 32 Millimeter FDA UDIOuter Diameter — 50 Millimeter FDA UDI
Category: Bipolar femoral head outer component, hemiarthroplasty
United Hip System, U2 Bipolar Implant by United Orthopedic Corp. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bipolar femoral head outer component, hemiarthroplasty.
- Pivot Bipolar — ORTHO DEVELOPMENT CORP. · Class II
- BIO-MOORE ENDO II HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- TANDEM — Smith & Nephew, Inc. · Class II
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Endohead — Medacta International · Class II
- UHR — Howmedica Osteonics Corp. · Class II
- SLR BIPOLAR — MicroPort Orthopedics Inc. · Class II
- MultiPolar® — Zimmer, Inc. · Class II
Cleared under the same submission
K101670 also covers:
- U2 Bipolar Implant — UNITED ORTHOPEDIC CORP.
- U2 Bipolar Implant — UNITED ORTHOPEDIC CORP.
- U2 Bipolar Implant — UNITED ORTHOPEDIC CORP.
- U2 Bipolar Implant — UNITED ORTHOPEDIC CORP.
- U2 Bipolar Implant — UNITED ORTHOPEDIC CORP.
- U2 Bipolar Implant — UNITED ORTHOPEDIC CORP.
- United Hip System, U2 Bipolar Implant — UNITED ORTHOPEDIC CORP.
- United Hip System, U2 Bipolar Implant — UNITED ORTHOPEDIC CORP.
- United Hip System, U2 Bipolar Implant — UNITED ORTHOPEDIC CORP.
- United Hip System, U2 Bipolar Implant — UNITED ORTHOPEDIC CORP.
- United Hip System, U2 Bipolar Implant — UNITED ORTHOPEDIC CORP.
- United Hip System, U2 Bipolar Implant — 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 356b3c0e-0946-4646-a298-42765d7f46b2 37 fields · synced Oct 7, 2026
- EUDAMED 15a593e5-df9e-4f2b-abac-90a837127f66 61 fields · synced Oct 7, 2026