Mrs

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name: MRS FDA UDI
Generic Name: Knee femur stem prosthesis FDA UDI
Device Name: Straight Cemented Stem FDA UDI
Model / Reference: 6485-3-111 FDA UDI
Description: Straight Cemented Stem FDA UDI

Identifiers

Catalog Number: 6485-3-111 FDA UDI
Primary DI / UDI-DI: 07613327048360 FDA UDI
510(k) Number: K040749 FDA UDI
K222056 FDA UDI
FDA Product Code: KRO FDA UDI
GMDN Term: Knee femur stem prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3510 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

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 127.0 Millimeter FDA UDI

Category: Knee femur stem prosthesis

Mrs by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Knee femur stem prosthesis.

Endo-Model Standard Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG · Class II
Biomet Knee System — Biomet Orthopedics, Inc. · Class II
Unity Total Knee System — CORIN LTD · Class II
LINK Endo-Model EVO — WALDEMAR LINK GmbH & Co. KG · Class II
OPTILOCK PERIARTICULAR PLATING SYSTEM — Biomet Orthopedics, Inc. · Class II
Evolution Revision CCK System — MicroPort Orthopedics Inc. · Class II
Modular Stem, — WALDEMAR LINK GmbH & Co. KG · Class II
LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG · Class II

Cleared under the same submission

K040749 also covers:

K222056 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: Howmedica Osteonics Corp.

Sources (1)

FDA UDI cf11f847-7b2e-4adb-bb11-e9101b47e9cb 36 fields · synced May 31, 2026