iTotal® Identity Cruciate Retaining Knee Replacement System

FDA UDI

Class II (US FDA UDI)

by Conformis, Inc.

Identity

Trade Name: iTotal® Identity Cruciate Retaining Knee Replacement System FDA UDI
Generic Name: Body femoral/tibial extension stem, uncoated FDA UDI
Device Name: ITOTAL IDENTITY 12X40MM TIBIAL STEM EXTENSION (TITANIUM, CEMENTED) FDA UDI
Model / Reference: STM301124001 FDA UDI
Description: ITOTAL IDENTITY 12X40MM TIBIAL STEM EXTENSION (TITANIUM, CEMENTED) FDA UDI

Identifiers

Catalog Number: STM3011240 FDA UDI
Primary DI / UDI-DI: M572STM3011240011 FDA UDI
FDA Product Code: OIY FDA UDI
OOG FDA UDI
JWH FDA UDI
GMDN Term: Body femoral/tibial extension stem, uncoated 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

Dimensions & Sizes

Size: Length — 40 Millimeter FDA UDI

Category: Body femoral/tibial extension stem, uncoated

iTotal® Identity Cruciate Retaining Knee Replacement System by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Conformis, Inc.

Sources (1)

FDA UDI ddb72f7f-45c4-4d20-ba63-bd6ee58bbf67 36 fields · synced May 30, 2026