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: PALACOS® fastR+G is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant - bone. The antibiotic gentamicin sulphate has been added to protect the cured cement and contiguous tissue against contamination by microbes sensitive to gentamicin. PALACOS® fastR+G is available in 51 g packaging size. PALACOS® fast R+G is indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary. The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared. FDA UDI
Model / Reference: fast R+G FDA UDI
Description: PALACOS® fastR+G is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant - bone. The antibiotic gentamicin sulphate has been added to protect the cured cement and contiguous tissue against contamination by microbes sensitive to gentamicin. PALACOS® fastR+G is available in 51 g packaging size. PALACOS® fast R+G is indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary. The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared. FDA UDI

Identifiers

Catalog Number: 66057601 FDA UDI
Primary DI / UDI-DI: 04260102136069 FDA UDI
510(k) Number: K190766 FDA UDI
FDA Product Code: LOD FDA UDI
MBB FDA UDI
GMDN Term: Orthopaedic cement, antimicrobial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3027 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

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

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 a670929f-5690-48a9-8d42-a7341bdc61b9 35 fields · synced May 30, 2026