Profemur®

FDA UDI

Class II (US FDA UDI)

by MicroPort Orthopedics Inc.

Identity

Trade Name: PROFEMUR® FDA UDI
Generic Name: Coated femoral stem prosthesis, modular FDA UDI
Device Name: PROFEMUR® LX REV 5/8 COATED STEM SZ 12 FDA UDI
Model / Reference: LUXR5812 FDA UDI
Description: PROFEMUR® LX REV 5/8 COATED STEM SZ 12 FDA UDI

Identifiers

Catalog Number: LUXR5812 FDA UDI
Primary DI / UDI-DI: M684LUXR58121 FDA UDI
FDA Product Code: LZO FDA UDI
MBL FDA UDI
GMDN Term: Coated femoral stem prosthesis, modular FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3358 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Coated femoral stem prosthesis, modular

Profemur® by MicroPort Orthopedics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coated femoral stem prosthesis, modular.

MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
TheRay Collared and Collarless Femoral Stem — Nextstep Arthropedix · Class II
STERIZO Total Hip System — CPM Medical Consultants, LLC · Class II
MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
Alteon — Exactech, Inc. · Class II
ANTHOLOGY — Smith & Nephew, Inc. · Class III
TheRay Collared and Collarless Femoral Stem — Nextstep Arthropedix · Class II
Origin DAA Stem, Coxa Vara — SIGNATURE ORTHOPAEDICS PTY LTD · Class II

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: MicroPort Orthopedics Inc.

Sources (1)

FDA UDI 9c9d65ee-04b9-4797-97f7-58f8780bb171 35 fields · synced Jun 9, 2026