Kinematic

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name: Kinematic FDA UDI
Generic Name: Rotating hinged total knee prosthesis FDA UDI
Device Name: Rotating Hinge Knee FDA UDI
Model / Reference: 6485-2-208 FDA UDI
Description: Rotating Hinge Knee FDA UDI

Identifiers

Catalog Number: 6485-2-208 FDA UDI
Primary DI / UDI-DI: 07613327047523 FDA UDI
510(k) Number: K001548 FDA UDI
K223069 FDA UDI
K972863 FDA UDI
FDA Product Code: JWH FDA UDI
GMDN Term: Rotating hinged total knee prosthesis 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

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

Category: Rotating hinged total knee prosthesis

Kinematic 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

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 914fe52f-0e76-478c-abfc-101621401270 36 fields · synced May 30, 2026