FDA.reportPublic FDA data

PALACOS®

Primary DI
04260102136168
Brand
PALACOS®
Company
Heraeus Medical GmbH
Model
R pro 80
Catalog number
5081287
Device description
The PALACOS® R pro system consists of a mixing and application system prefilled with PALACOS® polymer powder and monomer liquid. PALACOS® R 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.
Published
2021-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LODBone Cement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LODBone CementOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210607000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210607000PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proHeraeus Medical GmbH2021-07-09LOD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260102136168PackageGS16In Commercial Distribution
04260102136175PackageGS1144In Commercial Distribution
04260102136151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260102136168042601021361684260102136168
04260102136175042601021361754260102136175
04260102136151042601021361514260102136151

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement, non-antimicrobialA substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene. This device does not contain an antimicrobial agent. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
333623937
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260102133044COPAL® exchange GTrial Set knee50926072020-07-07
04260102139329COPAL® knee mould Trial M USM51659232023-06-25
04260102139350COPAL® knee mould Trial L USL51659242023-06-25
04260102139381COPAL® knee mould Trial S USS51598742023-06-25
04260102139411OSTEOPAL®V51309822025-09-26
04260102139428OSTEOPAL®V51309822025-09-26
04260102139855COPAL® G+V1x4051842672024-06-10
04260102139862COPAL® G+V1x4051842672024-06-10
04260102136670COPAL® exchange Ghip S long50347922019-11-25
04260102136700COPAL® exchange Ghip M long50347902019-11-25
04260102136731COPAL® exchange G hip L long50347852019-11-25
04260102136762COPAL® exchange Ghip XL long50347942019-11-25
04260102136793COPAL® exchange Ghip S short50347932019-11-25
04260102136823COPAL® exchange Ghip M short50347912019-11-25
04260102136854COPAL® exchange Ghip L short50347882019-11-25
04260102139176COPAL® exchange Ghip S medium51472152022-05-15
04260102139206COPAL® exchange Ghip M medium51472162022-05-15
04260102136885COPAL® exchange Ghip XL short50347952019-11-25
04260102136694COPAL® exchange Ghip S long50347922019-11-25
04260102136724COPAL® exchange Ghip M long50347902019-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760177044326Signature -x Cement TEKNIMEDLOD2026-01-23
03760177044333Signature -x Cement TEKNIMEDLOD2026-01-23
03760177044340Signature -x Cement TEKNIMEDLOD2026-01-23
04260102139411OSTEOPAL®Heraeus Medical GmbHLOD2025-09-26
04260102139428OSTEOPAL®Heraeus Medical GmbHLOD2025-09-26
03760177040090GENTAFIXTEKNIMEDLOD2025-09-02
03760177040137GENTAFIXTEKNIMEDLOD2025-09-02
03760177043176GENTAFIXTEKNIMEDLOD2025-09-02
07898315500901Bone Cement - Normal ViscosityBiomecânica Indústria e Comércio de Produtos Ortopédicos Ltda.LOD2025-04-23
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONLOD2024-11-21
08058964729033Arthrex Bone Cement HVG21 SRLLOD2024-10-04
08058964729040Arthrex Bone Cement MVG21 SRLLOD2024-10-04
08058964728647Arthrex Bone Cement HVG21 SRLLOD2024-09-16
08058964728678BRAVO HVG21 SRLLOD2024-09-16
08058964728722Arthrex Bone Cement HV w/GG21 SRLLOD2024-09-16
08058964728739Arthrex Bone Cement MVG21 SRLLOD2024-09-16
08058964728746Arthrex Bone Cement MV w/GG21 SRLLOD2024-09-16
08058964729002BRAVO MVG21 SRLLOD2024-09-16
08058964729019BRAVO MV+GG21 SRLLOD2024-09-16
08058964729026BRAVO HV+GG21 SRLLOD2024-09-16
04260056882579BonOs HVOSARTIS GmbHLOD2024-05-17
04260056882623BonOs HV GentaOSARTIS GmbHLOD2024-04-03
03770007907752V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27
03770007907769V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27
03770007907776V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27
03770007907783V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27
03770007907790V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27
03770007907806V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27
03770007907813V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27
03770007907820V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27