Identity
- Trade Name
- Klassic BiPolar Head, 45 mm OD, 28 mm Head FDA UDI
- Generic Name
- Bipolar femoral head outer component, hemiarthroplasty FDA UDI
- Model / Reference
- 3205.45.028 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814703011979 FDA UDI
- 510(k) Number
- K143113 FDA UDI
- FDA Product Code
- KWY FDA UDI
- GMDN Term
- Bipolar femoral head outer component, hemiarthroplasty FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3390 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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
Ethylene Oxide FDA UDI
Category: Bipolar femoral head outer component, hemiarthroplasty
Klassic BiPolar Head, 45 mm OD, 28 mm Head by Total Joint Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — 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
K143113 also covers:
- 22mm Femoral Head, 12/14 taper, +0mm offset — TOTAL JOINT ORTHOPEDICS, INC.
- 22mm Femoral Head, 12/14 taper, +3.5mm offset — TOTAL JOINT ORTHOPEDICS, INC.
- 22mm Femoral Head, 12/14 taper, +7mm offset — TOTAL JOINT ORTHOPEDICS, INC.
- 28mm Femoral Head, 12/14 taper, +0mm offset — TOTAL JOINT ORTHOPEDICS, INC.
- 28mm Femoral Head, 12/14 taper, +3.5mm offset — TOTAL JOINT ORTHOPEDICS, INC.
- 28mm Femoral Head, 12/14 taper, +7mm offset — TOTAL JOINT ORTHOPEDICS, INC.
- 28mm Femoral Head, 12/14 taper, -3.5mm offset — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic BiPolar Head, 38 mm OD, 22 mm Head — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic BiPolar Head, 39 mm OD, 22 mm Head — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic BiPolar Head, 40 mm OD, 22 mm Head — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic BiPolar Head, 41 mm OD, 22 mm Head — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic BiPolar Head, 42 mm OD, 22 mm Head — TOTAL JOINT ORTHOPEDICS, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Total Joint Orthopedics, Inc.
Sources (1)
- FDA UDI ed352c94-3b33-4cdb-aad9-e12093fa04dd 36 fields · synced May 31, 2026