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: Joint prosthesis implantation kit, single-use FDA UDI
Device Name: ITOTAL IDENTITY CR JIGS FDA UDI
Model / Reference: TCR000D00101 FDA UDI
Description: ITOTAL IDENTITY CR JIGS FDA UDI

Identifiers

Catalog Number: TCR000D001 FDA UDI
Primary DI / UDI-DI: M572TCR000D001011 FDA UDI
FDA Product Code: OIY FDA UDI
OOG FDA UDI
JWH FDA UDI
GMDN Term: Joint prosthesis implantation kit, single-use 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Joint prosthesis implantation kit, single-use

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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Also classified as Joint prosthesis implantation kit, single-use.

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Femoral Epimandrel — Episurf Operations AB · Class II
Blunt pin — Si-Bone Inc. · Class IIa
Y-KNOT — Conmed Corporation · Class IIa

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 3600acf9-c796-4015-b992-8e5943e31ae2 35 fields · synced May 31, 2026