Identity
- Trade Name
- PROFIX FDA UDI
- Generic Name
- Uncoated knee tibia prosthesis, polyethylene FDA UDI
- Device Name
- PROFIX CONFORMING TIBIAL INSERT RIGHT SIZE 4 14MM FDA UDI
- Model / Reference
- 71507143 FDA UDI
- Description
- PROFIX CONFORMING TIBIAL INSERT RIGHT SIZE 4 14MM FDA UDI
Identifiers
- Catalog Number
- 71507143 FDA UDI
- Primary DI / UDI-DI
- 03596010220028 FDA UDI
- 510(k) Number
- K933958 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Uncoated knee tibia prosthesis, polyethylene FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 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
Category: Uncoated knee tibia prosthesis, polyethylene
Profix by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated knee tibia prosthesis, polyethylene.
- Freedom — MAXX ORTHOPEDICS INC. · Class II
- World Knee Vit-E CR All Poly Tibia — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- Freedom — MAXX ORTHOPEDICS INC. · Class II
- Gemini SL — WALDEMAR LINK GmbH & Co. KG · Class II
- Triathlon — Howmedica Osteonics Corp. · Class II
- Freedom — MAXX ORTHOPEDICS INC. · Class II
- Freedom — MAXX ORTHOPEDICS INC. · Class II
- GMK Primary Total Knee System — Medacta International · Class II
Cleared under the same submission
K933958 also covers:
- LEGION — Smith & Nephew, Inc.
- LEGION — Smith & Nephew, Inc.
- LEGION — 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI b453345b-5507-4baf-b52a-d579aec275c9 36 fields · synced Jun 8, 2026