Genflex2 Total Knee System

FDA UDI

Class II (US FDA UDI)

by Globus Medical, Inc.

Identity

Trade Name: Genflex2 Total Knee System FDA UDI
Generic Name: Coated knee femur prosthesis FDA UDI
Device Name: GENflex2 CR Porous Coated Femur-Left, Size 1.5 FDA UDI
Model / Reference: SC3857-1.5 FDA UDI
Description: GENflex2 CR Porous Coated Femur-Left, Size 1.5 FDA UDI

Identifiers

Primary DI / UDI-DI: 10840843120988 FDA UDI
FDA Product Code: OIY FDA UDI
JWH FDA UDI
GMDN Term: Coated knee femur 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Coated knee femur prosthesis

Genflex2 Total Knee System by Globus Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coated knee femur prosthesis.

PHYSICA POROUS PS — Limacorporate · Class II
GMK Primary Total Knee System — Medacta International · Class II
PHYSICA POROUS KR — Limacorporate · Class II
PERSONA™ Trabecular Metal™ — Zimmer, Inc. · Class II
PERSONA™ Trabecular Metal™ — Zimmer, Inc. · Class II
Persona® PPS® — Zimmer, Inc. · Class II
SIGMA — DEPUY (IRELAND) · Class II
APEX PS Knee — OMNIlife science, Inc. · Class II

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: Globus Medical, Inc.

Sources (1)

FDA UDI add9e359-99a1-442c-97dc-a925dcbda071 34 fields · synced Jun 8, 2026