Gmrs

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name: GMRS FDA UDI
Generic Name: Rotating hinged total knee prosthesis FDA UDI
Device Name: Distal Femoral Component FDA UDI
Model / Reference: 6495-2-020 FDA UDI
Description: Distal Femoral Component FDA UDI

Identifiers

Catalog Number: 6495-2-020 FDA UDI
Primary DI / UDI-DI: 07613327048759 FDA UDI
510(k) Number: K023087 FDA UDI
K222056 FDA UDI
FDA Product Code: KRO FDA UDI
JDI FDA UDI
GMDN Term: Rotating hinged total knee prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3510 FDA UDI
888.3350 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 — 65.0 Millimeter FDA UDI

Category: Rotating hinged total knee prosthesis

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

Similar devices

Also classified as Rotating hinged total knee prosthesis.

LEGION — Smith & Nephew, Inc. · Class II
AS ENDURO — AESCULAP, INC. · Class II
Endo-Model Standard Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG · Class II
ATTUNE LPS — DEPUY (IRELAND) · Class II
Endo-Model Standard Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG · Class II
LEGION — Smith & Nephew, Inc. · Class II
Endo-Model Modular Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG · Class II
Endo-Model Standard Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG · Class II

Cleared under the same submission

K023087 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Howmedica Osteonics Corp.

Sources (1)

FDA UDI 4596c793-3a32-46f7-b4fe-71e2b1dbc4f4 36 fields · synced May 29, 2026