P.f.c. Sigma

FDA UDI

Class II (US FDA UDI)

by Depuy Orthopaedics, Inc.

Identity

Trade Name: P.F.C. SIGMA FDA UDI
Generic Name: Coated knee tibia prosthesis FDA UDI
Device Name: P.F.C. SIGMA TIBIAL TRAY FIXED BEARING KEEL TITANIUM POROCOAT 6 FDA UDI
Model / Reference: 96-7510 FDA UDI
Description: P.F.C. SIGMA TIBIAL TRAY FIXED BEARING KEEL TITANIUM POROCOAT 6 FDA UDI

Identifiers

Catalog Number: 967510 FDA UDI
Primary DI / UDI-DI: 10603295250043 FDA UDI
510(k) Number: K991106 FDA UDI
FDA Product Code: JWH FDA UDI
GMDN Term: Coated knee tibia prosthesis 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

Category: Coated knee tibia prosthesis

P.f.c. Sigma by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coated knee tibia prosthesis.

ADVANTIM® — MicroPort Orthopedics Inc. · Class II
Consensus Knee System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
Natural-Knee® — Zimmer, Inc. · Class II
Balanced Knee System — ORTHO DEVELOPMENT CORP. · Class II
OMNI Knee — OMNIlife science, Inc. · Class II
Columbus® CR/PS — AESCULAP, INC. · Class II
ADVANTIM® — MicroPort Orthopedics Inc. · Class II
JOURNEY — Smith & Nephew, Inc. · Class I

Cleared under the same submission

K991106 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 Orthopaedics, Inc.

Sources (1)

FDA UDI 618df39c-3606-4fc8-9e3d-9ea571294330 36 fields · synced Jun 8, 2026