Sigma

FDA UDI

Class II (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name: SIGMA FDA UDI
Generic Name: Uncoated unicondylar knee femur prosthesis FDA UDI
Device Name: SIGMA HIGH PERFORMANCE PARTIAL KNEE PFJ TROCHLEA SIZE 4 RIGHT CEMENTED FDA UDI
Model / Reference: 1024-04-400 FDA UDI
Description: SIGMA HIGH PERFORMANCE PARTIAL KNEE PFJ TROCHLEA SIZE 4 RIGHT CEMENTED FDA UDI

Identifiers

Catalog Number: 102404400 FDA UDI
Primary DI / UDI-DI: 10603295001690 FDA UDI
510(k) Number: K061648 FDA UDI
K233980 FDA UDI
FDA Product Code: NPJ FDA UDI
KRR FDA UDI
HRY FDA UDI
GMDN Term: Uncoated unicondylar knee femur prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
888.3540 FDA UDI
888.3530 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: Uncoated unicondylar knee femur prosthesis

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

Similar devices

Also classified as Uncoated unicondylar knee femur prosthesis.

HLS Uni Evolution — CORIN LTD · Class II
Unicondylar Knee System — GLOBUS MEDICAL, INC. · Class II
iUni® Femoral Kit — Conformis, Inc. · Class II
Persona® Partial Knee System — Biomet Orthopedics, Inc. · Class II
Unicondylar Knee System — GLOBUS MEDICAL, INC. · Class II
JOURNEY — Smith & Nephew, Inc. · Class II
JOURNEY — Smith & Nephew, Inc. · Class II
GENESIS — Smith & Nephew, Inc. · Class II

Cleared under the same submission

K061648 also covers:

K233980 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Depuy (ireland)

Sources (1)

FDA UDI 9e5a870c-e6d6-454c-b097-d99c3c8714a3 36 fields · synced May 30, 2026