iUni iPoly Implant

FDA UDI

Class II (US FDA UDI)

by Conformis, Inc.

Identity

Trade Name: iUni iPoly Implant FDA UDI
Generic Name: Unicondylar knee prosthesis FDA UDI
Device Name: IUNI–IPOLY–IMPLANT KIT–RIGHT or Left LATERAL or medial FDA UDI
Model / Reference: UKA-111-111103 FDA UDI
Description: IUNI–IPOLY–IMPLANT KIT–RIGHT or Left LATERAL or medial FDA UDI

Identifiers

Catalog Number: UKA-111-1111 FDA UDI
Primary DI / UDI-DI: M572UKA1111111031 FDA UDI
510(k) Number: K111916 FDA UDI
FDA Product Code: HSX FDA UDI
OOG FDA UDI
GMDN Term: Unicondylar knee prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3520 FDA UDI
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

Category: Unicondylar knee prosthesis

iUni iPoly Implant by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Unicondylar knee prosthesis.

Engage Partial Knee System — Engage Uni, LLC · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
Oxford® Partial Knee System — Biomet Orthopedics, Inc. · Class II
LEGION — Smith & Nephew, Inc. · Class II
RESTORIS ESYNTIAL — MAKO Surgical Corp. · Class II
RESTORIS ESYNTIAL — MAKO Surgical Corp. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
GENESIS II — Smith & Nephew, 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 fade6be1-4071-41d7-91f3-c0113d1ed03e 36 fields · synced May 31, 2026