iTotal Identity PS

FDA UDI

Class II (US FDA UDI)

by Conformis, Inc.

Identity

Trade Name: iTotal Identity PS FDA UDI
Generic Name: Uncoated knee femur prosthesis, metallic FDA UDI
Device Name: ITOTAL IDENTITY PS FEMORAL IMPLANT (COCR, CEMENTED), RIGHT or left FDA UDI
Model / Reference: TPS-101-111211 FDA UDI
Description: ITOTAL IDENTITY PS FEMORAL IMPLANT (COCR, CEMENTED), RIGHT or left FDA UDI

Identifiers

Catalog Number: TPS-101-1112 FDA UDI
Primary DI / UDI-DI: M572TPS1011112111 FDA UDI
510(k) Number: K201023 FDA UDI
FDA Product Code: JWH FDA UDI
OIY FDA UDI
OOG FDA UDI
GMDN Term: Uncoated knee femur prosthesis, metallic 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Uncoated knee femur prosthesis, metallic

iTotal Identity PS by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Uncoated knee femur prosthesis, metallic.

SIGMA — DEPUY (IRELAND) · Class II
Natural-Knee® — Zimmer, Inc. · Class II
LEGION — Smith & Nephew, Inc. · Class II
LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG · Class II
Orthopedic Salvage System (OSS™) — Biomet Orthopedics, Inc. · Class II
GMK Sphere Revision System — Medacta International · Class II
ACS® — implantcast GmbH · Class II
Balance Knee Revision System — ORTHO DEVELOPMENT CORP. · Class II

Cleared under the same submission

K201023 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: Conformis, Inc.

Sources (1)

FDA UDI 3681cce9-79f2-457d-a95d-6f58ddef59c2 37 fields · synced Jun 8, 2026