Sigma

FDA UDI

Class II (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name: SIGMA FDA UDI
Generic Name: Unicondylar knee insert FDA UDI
Device Name: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 2LM/RL 8MM FDA UDI
Model / Reference: 1024-55-208 FDA UDI
Description: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 2LM/RL 8MM FDA UDI

Identifiers

Catalog Number: 102455208 FDA UDI
Primary DI / UDI-DI: 10603295501510 FDA UDI
510(k) Number: K193549 FDA UDI
FDA Product Code: HRY FDA UDI
OIY FDA UDI
GMDN Term: Unicondylar knee insert FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3530 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

Category: Unicondylar knee insert

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

Similar devices

Also classified as Unicondylar knee insert.

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Vivacit-E® — Zimmer, Inc. · Class II
Unicondylar Knee System — GLOBUS MEDICAL, INC. · Class II
MOTO Partial Knee System - Medial — Medacta International · Class II
GENESIS — Smith & Nephew, Inc. · Class II
JOURNEY — Smith & Nephew, Inc. · Class II
GMK Uni — Medacta International · Class II
GENESIS — Smith & Nephew, Inc. · Class II

Cleared under the same submission

K193549 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: Depuy (ireland)

Sources (1)

FDA UDI c33426eb-a132-48fd-91af-279dfd999721 36 fields · synced May 30, 2026