Identity
- Trade Name
- Paxeon BiPolar Head FDA UDI
- Generic Name
- Bipolar femoral head outer component, hemiarthroplasty FDA UDI
- Device Name
- Bipolar Head Size 28/49 FDA UDI
- Model / Reference
- PR111-21-2849 FDA UDI
- Description
- Bipolar Head Size 28/49 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08177570201891 FDA UDI
- 510(k) Number
- K133370 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
Yes
FDA UDI
Category: Bipolar femoral head outer component, hemiarthroplasty
Paxeon BiPolar Head by Paxeon Reconstruction Llc — 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
K133370 also covers:
- SKYLON Stem — Amplitude
- SKYLON Stem — Amplitude
- SKYLON Stem — Amplitude
- SKYLON Stem — Amplitude
- SKYLON Stem — Amplitude
- SKYLON Stem — Amplitude
- SKYLON Stem — Amplitude
- OrthoMedFlex — ORTHOMEDFLEX LLC
- OrthoMedFlex — ORTHOMEDFLEX LLC
- OrthoMedFlex — ORTHOMEDFLEX LLC
- OrthoMedFlex — ORTHOMEDFLEX LLC
- Paxeon BiPolar Head — PAXEON RECONSTRUCTION LLC
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
- Paxeon Reconstruction Llc
Sources (1)
- FDA UDI 79daab4e-d297-4ebd-bb08-3bf8770e12d7 34 fields · synced May 30, 2026