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 femur prosthesis, metallic FDA UDI
Device Name: P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING CEMENTED 5 LEFT FDA UDI
Model / Reference: 96-0045 FDA UDI
Description: P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING CEMENTED 5 LEFT FDA UDI

Identifiers

Catalog Number: 960045 FDA UDI
Primary DI / UDI-DI: 10603295232254 FDA UDI
510(k) Number: K241000 FDA UDI
K950010 FDA UDI
K952830 FDA UDI
K971189 FDA UDI
FDA Product Code: JWH FDA UDI
GMDN Term: Uncoated knee femur prosthesis, metallic 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 femur prosthesis, metallic

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 femur prosthesis, metallic.

Natural-Knee® — Zimmer, Inc. · Class II
LEGION — Smith & Nephew, Inc. · Class II
LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG · Class II
Orthopedic Salvage System (OSS™) — Biomet Orthopedics, Inc. · Class II
GMK Sphere Revision System — Medacta International · Class II
ACS® — implantcast GmbH · Class II
Balance Knee Revision System — ORTHO DEVELOPMENT CORP. · Class II
LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KG · Class II

Cleared under the same submission

K241000 also covers:

K950010 also covers:

K952830 also covers:

K971189 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 5d5a12e9-402b-46cc-86a6-c512862cb060 36 fields · synced Jun 1, 2026