Identity
- Trade Name
- PROFIX FDA UDI
- Generic Name
- Uncoated knee femur prosthesis, metallic FDA UDI
- Device Name
- PROFIX CONSTRAINED NONPOR FEMORAL W/TAPER SZ5 LT FDA UDI
- Model / Reference
- 71522256 FDA UDI
- Description
- PROFIX CONSTRAINED NONPOR FEMORAL W/TAPER SZ5 LT FDA UDI
Identifiers
- Catalog Number
- 71522256 FDA UDI
- Primary DI / UDI-DI
- 03596010419392 FDA UDI
- 510(k) Number
- K954909 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Uncoated knee femur prosthesis, metallic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Contains Latex
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
The PROFIX CONSTRAINED NONPOR FEMORAL W/TAPER SZ5 LT knee prosthesis is an implantable device designed for primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision). It consists of a metallic component made from cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), and titanium (Ti) that articulates with tibial and patellar prosthetic components. The device is sterilized with MAP (Medical Apparatus Protocol) and has a customer contact email and phone number for purchase inquiries.
Cleared under the same submission
K954909 also covers:
- PROFIX — Smith & Nephew, Inc.
- PROFIX — Smith & Nephew, Inc.
- PROFIX — Smith & Nephew, Inc.
- PROFIX — Smith & Nephew, Inc.
- PROFIX — Smith & Nephew, Inc.
- PROFIX — Smith & Nephew, Inc.
- PROFIX — Smith & Nephew, Inc.
- PROFIX — Smith & Nephew, Inc.
- PROFIX — Smith & Nephew, Inc.
- PROFIX — Smith & Nephew, Inc.
- PROFIX — Smith & Nephew, Inc.
- PROFIX — Smith & Nephew, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 4fab1fed-4fed-4a2d-9b30-63235ea9129a 37 fields · synced Jul 30, 2026