FDA.reportPublic FDA data

PALACOS

Primary DI
J014001113140011
Brand
PALACOS
Company
Heraeus Medical GmbH
Model
R+G
Catalog number
00-1113-140-01
Device description
PALACOS® R+G is a fast setting polymer containing gentamicin, for use in bone surgery. Mixing of the two component system, consisting of a powder and a liquid, initially produces a liquid and then a paste, which is used to anchor the prosthesis to the bone. The hardened bone cement allows stable fixation of the prosthesis and Transfers all stresses produced in a movement to the bone via the large interface. Insoluble zirconium dioxide is included in the cement powder as an X ray contrast medium. The chlorophyll additive serves as optical marking of the bone cement at the site of the operation.
Published
2015-06-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LODBone Cement
MBBBone Cement, Antibiotic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LODBone CementOrthopedic2
MBBBone Cement, AntibioticOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031673000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031673000REFOBACIN -PALACOS GHeraeus Kulzer GmbH & Co. KG2004-05-25LOD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J014001113140012PackageHIBCC20Not in Commercial Distribution
J014001113140011PrimaryHIBCC0

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 Temperature0 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
333623937
Device count
1
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
00887868551611StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551628StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551635StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551659StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551666StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551673StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551680StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
08031497003955Interspace GV Hip Spacer 46TECRES SPAMBB2026-02-11
08031497003962Interspace GV Hip Spacer 54TECRES SPAMBB2026-02-11
08031497003979Interspace GV Hip Spacer 60TECRES SPAMBB2026-02-11
08031497003986Interspace GV Hip Spacer 46 XLTECRES SPAMBB2026-02-11
08031497003993Interspace GV Hip Spacer 54 XLTECRES SPAMBB2026-02-11
08031497004006Interspace GV Hip Spacer 60 XLTECRES SPAMBB2026-02-11
03760177044326Signature -x Cement TEKNIMEDMBB2026-01-23
03760177044333Signature -x Cement TEKNIMEDMBB2026-01-23
03760177044340Signature -x Cement TEKNIMEDMBB2026-01-23
03760177040090GENTAFIXTEKNIMEDMBB2025-09-02
03760177040137GENTAFIXTEKNIMEDMBB2025-09-02
03760177043176GENTAFIXTEKNIMEDMBB2025-09-02
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONLOD2024-11-21
08058964728722Arthrex Bone Cement HV w/GG21 SRLMBB2024-09-16
08058964728746Arthrex Bone Cement MV w/GG21 SRLMBB2024-09-16
08058964729019BRAVO MV+GG21 SRLMBB2024-09-16
08058964729026BRAVO HV+GG21 SRLMBB2024-09-16
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