Itotal Ipoly Xe 38mm X 9mm Cemented Oval Patella Implant

FDA UDI

Class II (US FDA UDI)

by Conformis, Inc.

Identity

Trade Name: ITOTAL IPOLY XE 38MM X 9MM CEMENTED OVAL PATELLA IMPLANT FDA UDI
Generic Name: Polyethylene patella prosthesis FDA UDI
Model / Reference: POV021380901 FDA UDI

Identifiers

Catalog Number: POV0213809 FDA UDI
Primary DI / UDI-DI: M572POV0213809011 FDA UDI
FDA Product Code: JWH FDA UDI
GMDN Term: Polyethylene patella 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Polyethylene patella prosthesis

Itotal Ipoly Xe 38mm X 9mm Cemented Oval Patella Implant by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Proven Gen-Flex PS Knee System — GLOBUS MEDICAL, INC. · Class II

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 f8284840-592a-429e-9e61-7c3aac960d1b 35 fields · synced May 29, 2026