Palacos®

FDA UDI

Class II (US FDA UDI)

by Heraeus Medical LLC

Identity

Trade Name: PALACOS® FDA UDI
Generic Name: Orthopaedic cement, antimicrobial FDA UDI
Device Name: The PALACOS® R+G pro system consists of a mixing and application system prefilled with PALACOS® polymer powder and monomer liquid. PALACOS® R+G pro is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone. FDA UDI
Model / Reference: R+G pro 40 FDA UDI
Description: The PALACOS® R+G pro system consists of a mixing and application system prefilled with PALACOS® polymer powder and monomer liquid. PALACOS® R+G pro is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone. FDA UDI

Identifiers

Catalog Number: 5081288 FDA UDI
Primary DI / UDI-DI: 04260102136182 FDA UDI
510(k) Number: K210607 FDA UDI
FDA Product Code: MBB FDA UDI
KIH FDA UDI
JDZ FDA UDI
LOD FDA UDI
GMDN Term: Orthopaedic cement, antimicrobial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3027 FDA UDI
888.4200 FDA UDI
888.4210 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

Yes

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 Safe FDA UDI

Category: Orthopaedic cement, antimicrobial

Palacos® by Heraeus Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic cement, antimicrobial.

BonOs HV Genta — OSARTIS GmbH · Class II
Refobacin® Bone Cement R — Biomet, Inc. · Class II
Unite Cement — OSTEOREMEDIES, LLC · Class II
MectaCem-X LV with Gentamicin — Tecres · Class II
BRAVO MV+G — G21 SRL · Class II
Simplex — Howmedica Osteonics Corp. · Class II
Cemex Genta HV — Tecres · Class II
REFOBACIN® BONE CEMENT R — Biomet, Inc. · Class II

Cleared under the same submission

K210607 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: Heraeus Medical LLC

Sources (1)

FDA UDI 28eb2ce9-39c2-4856-a864-7806a716d90f 36 fields · synced May 30, 2026