Attune Aox Affixium

FDA UDI

Class II (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name: ATTUNE AOX AFFIXIUM FDA UDI
Generic Name: Metal-backed patella prosthesis FDA UDI
Device Name: ATTUNE AOX AFFIXIUM KNEE SYSTEM PATELLA MEDIALIZED ANATOMIC 35mm FDA UDI
Model / Reference: 1518-11-035 FDA UDI
Description: ATTUNE AOX AFFIXIUM KNEE SYSTEM PATELLA MEDIALIZED ANATOMIC 35mm FDA UDI

Identifiers

Catalog Number: 151811035 FDA UDI
Primary DI / UDI-DI: 10603295523765 FDA UDI
FDA Product Code: MBH FDA UDI
JWH FDA UDI
GMDN Term: Metal-backed patella prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3565 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Metal-backed patella prosthesis

Attune Aox Affixium by Depuy (ireland) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Metal-backed patella prosthesis.

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LCS COMPLETE — DEPUY ORTHOPAEDICS, INC. · Class III
Triathlon — Howmedica Osteonics Corp. · Class II
Triathlon — Howmedica Osteonics Corp. · Class II
LCS COMPLETE — DEPUY ORTHOPAEDICS, INC. · Class III

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: Depuy (ireland)

Sources (1)

FDA UDI 80eaec65-a538-447a-9b08-25787abd59da 35 fields · synced May 29, 2026