Profix

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: PROFIX FDA UDI
Generic Name: Joint prosthesis implantation kit, reusable FDA UDI
Device Name: PROFIX CAS FEM CUTTING BLOCK SZ 5 FDA UDI
Model / Reference: 71582350 FDA UDI
Description: PROFIX CAS FEM CUTTING BLOCK SZ 5 FDA UDI

Identifiers

Catalog Number: 71582350 FDA UDI
Primary DI / UDI-DI: 03596010482051 FDA UDI
510(k) Number: K012938 FDA UDI
FDA Product Code: HAW FDA UDI
GMDN Term: Joint prosthesis implantation kit, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Joint prosthesis implantation kit, reusable

Profix by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Joint prosthesis implantation kit, reusable.

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PROPHECY — MicroPort Orthopedics Inc. · Class II
IMPLANT PARTNERS™ — MicroPort Orthopedics Inc. · Class I
Evolution — MicroPort Orthopedics Inc. · Class II
GUARDIAN® — MicroPort Orthopedics Inc. · Class I
ADVANCE® — MicroPort Orthopedics Inc. · Class I
PROPHECY — MicroPort Orthopedics Inc. · Class II
GLADIATOR® — MicroPort Orthopedics Inc. · Class I

Cleared under the same submission

K012938 also covers:

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: Smith & Nephew, Inc.

Sources (1)

FDA UDI bdd0f621-2a86-46ff-8e60-e54342c7006f 36 fields · synced Jun 8, 2026