P.f.c. Sigma

FDA UDI

Class II (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name: P.F.C. SIGMA FDA UDI
Generic Name: Uncoated knee tibia prosthesis, polyethylene FDA UDI
Device Name: P.F.C. SIGMA TIBIAL TRAY FIXED BEARING MODULAR TITANIUM 3 CEMENTED FDA UDI
Model / Reference: 86-6023 FDA UDI
Description: P.F.C. SIGMA TIBIAL TRAY FIXED BEARING MODULAR TITANIUM 3 CEMENTED FDA UDI

Identifiers

Catalog Number: 866023 FDA UDI
Primary DI / UDI-DI: 10603295216780 FDA UDI
510(k) Number: K241000 FDA UDI
K882234 FDA UDI
K884796 FDA UDI
FDA Product Code: JWH FDA UDI
GMDN Term: Uncoated knee tibia prosthesis, polyethylene 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: Uncoated knee tibia prosthesis, polyethylene

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

Similar devices

Also classified as Uncoated knee tibia prosthesis, polyethylene.

Freedom — MAXX ORTHOPEDICS INC. · Class II
JOURNEY — Smith & Nephew, Inc. · Class II
JII — Smith & Nephew, Inc. · Class II
World Knee Vit-E CR All Poly Tibia — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Freedom — MAXX ORTHOPEDICS INC. · Class II
Gemini SL — WALDEMAR LINK GmbH & Co. KG · Class II
TC-PLUS Primary — Smith & Nephew, Inc. · Class II
Triathlon — Howmedica Osteonics Corp. · Class II

Cleared under the same submission

K241000 also covers:

K882234 also covers:

K884796 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 c17d267b-5789-4300-8f6c-3f33fc3f4717 36 fields · synced May 30, 2026