FDA.reportPublic FDA data

Orthopaedic cement, antimicrobial

Definition
A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic prosthetic implants to the living bone and/or to fill voids in the case of bone pathologies, and to treat infected joint prostheses or osteomyelitis; it may also be used prophylactically in primary or uninfected revision total joint arthroplasty. It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene, and contains an antimicrobial agent. After application, this device cannot be reused.
GUDID devices
40
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04260056885679BonOs R Genta 1x40OSARTIS GmbH01-02172015-09-25
04260056885761Simplex HV with GentamicinOSARTIS GmbH6195-1-0012015-09-24
04260102136069PALACOS®Heraeus Medical GmbHfast R+G2019-06-13
04260102136182PALACOS®Heraeus Medical GmbHR+G pro 402021-07-15
04260102136212PALACOS®Heraeus Medical GmbHR+G pro 802021-07-15
04260102136243PALACOS®Heraeus Medical GmbHMV+G pro 402021-07-15
04260102136274PALACOS®Heraeus Medical GmbHMV+G pro 802021-07-15
04260102139855COPAL® G+VHeraeus Medical GmbH1x402024-06-10
07613327128420SimplexHowmedica Osteonics Corp.6197-9-0012017-06-19
07613327128451SimplexHowmedica Osteonics Corp.6192-1-0012017-06-19
08058964720122G3A 40 Bone CementG21 SRL8000092019-03-08
08058964726759OrthoSteady GG21 SRL8000192018-05-03
10195594567743CARDINAL HEALTHCardinal Health 200, LLCSBACNUBOL32022-03-01
10195594837150CARDINAL HEALTHCardinal Health 200, LLC34-6921H2022-09-26
10603295174264NADEPUY (IRELAND)5450-31-5002015-09-24
10603295174271NADEPUY (IRELAND)5450-32-5002015-09-24
10603295174288SMARTSETDEPUY (IRELAND)5450-35-5002015-09-24
10603295174295SMARTSETDEPUY (IRELAND)5450-50-5012015-09-24
10885380066528CARDINAL HEALTHCardinal Health 200, LLCCMT-40-1G2015-07-07
03760177044326Signature -x Cement TEKNIMEDSV2026-01-23
03760177044333Signature -x Cement TEKNIMEDLV2026-01-23
03760177044340Signature -x Cement TEKNIMEDMV2026-01-23
03760177040090GENTAFIXTEKNIMED12025-09-02
03760177040137GENTAFIXTEKNIMED32025-09-02
03760177043176GENTAFIXTEKNIMED3 MV2025-09-02
08058964728722Arthrex Bone Cement HV w/GG21 SRLAR-901-HVG2024-09-16
08058964728746Arthrex Bone Cement MV w/GG21 SRLAR-901-MVG2024-09-16
08058964729019BRAVO MV+GG21 SRL610-01-1402024-09-16
08058964729026BRAVO HV+GG21 SRL611-01-1402024-09-16
04260102139862COPAL® G+VHeraeus Medical GmbH1x402024-06-10
04260056882623BonOs HV GentaOSARTIS GmbH1x402024-04-03
50195594837158CARDINAL HEALTHCardinal Health 200, LLC34-6921H2022-09-26
50195594567741CARDINAL HEALTHCardinal Health 200, LLCSBACNUBOL32022-03-01
04260102136199PALACOS®Heraeus Medical GmbHR+G pro 402021-07-15
04260102136229PALACOS®Heraeus Medical GmbHR+G pro 802021-07-15
04260102136250PALACOS®Heraeus Medical GmbHMV+G pro 402021-07-15
04260102136281PALACOS®Heraeus Medical GmbHMV+G pro 802021-07-15
08031497002101Conflow G Bone CementTECRES SPA1100430262021-06-09
08031497002149MectaCem-X LV with GentamicinTECRES SPA65.01.113US2021-06-09
08031497002163MectaCem-X HV with Gentamicin TECRES SPA65.01.111US2021-06-09