FDA.reportPublic FDA data

Orthopaedic cement, non-antimicrobial

Definition
A 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.
GUDID devices
114
Last updated
2026-09-14 22:39:26

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10603295168324SMARTSETDEPUY (IRELAND)3092-0202015-09-24
10603295168331SMARTSETDEPUY (IRELAND)3092-0402015-09-24
10603295168614NADEPUY (IRELAND)3312-0402015-09-24
10603295168621NADEPUY (IRELAND)3322-0202015-09-24
10603295168638NADEPUY (IRELAND)3332-0402015-09-24
07613327141771SpinePlexSTRYKER CORPORATION04062220002016-09-23
28031497000101Mendec SpineTECRES SPA12302015-10-06
00884450843215StabiliT®Merit Medical Systems, Inc.B2026-04-15
00884450843222StabiliT®Merit Medical Systems, Inc.B2026-03-31
00889095258516CONCORDGLOBUS MEDICAL, INC.4129.2000S2015-11-07
00889095258523CONCORDGLOBUS MEDICAL, INC.4129.4000S2015-11-07
00889095343045CONCORDGLOBUS MEDICAL, INC.458.693S2015-12-09
03596010411020VERSABONDSmith & Nephew, Inc.712711402015-08-29
03596010494726VERSABONDSmith & Nephew, Inc.712713402015-08-29
03596010507372VERSABONDSmith & Nephew, Inc.712714402015-09-28
04260056885624BonOs R 1x40OSARTIS GmbH01-01172015-09-25
04260056885747Simplex HVOSARTIS GmbH6194-1-0012015-09-24
04260102130494OSTEOPAL®Heraeus Medical GmbHV2020-08-10
04260102132597OSTEOPAL®Heraeus Medical GmbHplus2020-08-10
04260102135369PALACOS®Heraeus Medical GmbHMV pro 802022-02-13
04260102136151PALACOS®Heraeus Medical GmbHR pro 802021-07-15
04260102139411OSTEOPAL®Heraeus Medical GmbHV2025-09-26
04546540039637BioPrepSTRYKER CORPORATION02067100002015-09-23
07613252018315PCD, VertaPlexSTRYKER CORPORATION05075890002016-12-29
07613252039259AutoPlex, VertaPlexSTRYKER CORPORATION06076870002017-01-03
07613327128437SimplexHowmedica Osteonics Corp.6188-1-0012015-09-24
07613327128444SimplexHowmedica Osteonics Corp.6191-1-0012015-09-24
07613327357851PCD, VertaPlexSTRYKER CORPORATION05075860002017-04-21
08058964720245V-FASTG21 SRL8000362017-03-29
08058964723819V-STEADYG21 SRL8000392017-03-29
10603295168355SMARTSETDEPUY (IRELAND)3102-0802015-09-24
10603295168362SMARTSETDEPUY (IRELAND)3122-0202015-09-24
10603295168379SMARTSETDEPUY (IRELAND)3122-0402015-09-24
10885380066511CARDINAL HEALTHCardinal Health 200, LLCCMT-40-12015-07-06
J014001113140011PALACOSHeraeus Medical GmbHR+G2015-06-01
J014001118140011PALACOS Heraeus Medical GmbHLV2015-06-01
J014001119140011PALACOSHeraeus Medical GmbHLV+G2015-06-01
J014002112140011PALACOSHeraeus Medical GmbHR2015-06-01
M684141010001ORTHOSET®Microport Orthopedics Inc.141010002015-10-24
M684141020001ORTHOSET®Microport Orthopedics Inc.141020002015-10-24
M684141030001ORTHOSET®Microport Orthopedics Inc.141030002015-10-24
04260102139428OSTEOPAL®Heraeus Medical GmbHV2025-09-26
00810131880736 OsteoFlo Synthetic HydroPutty HFP - 1ccSurgentec, LLCOHFP-S-012025-06-10
00810131880743OsteoFlo Synthetic HydroPutty HFP - 3cc Surgentec, LLCOHFP-S-032025-06-10
00810131880750OsteoFlo Synthetic HydroPutty HFP - 6ccSurgentec, LLCOHFP-S-062025-06-10
00810131880767 OsteoFlo Synthetic HydroPutty HFP - 12cc Surgentec, LLC OHFP-S-122025-06-10
00810131881139 OsteoFlo Synthetic Nanoputty Syringe - 5cc - IOSALSurgentec, LLC ONP-S-05 - IB2025-06-10
00810131881146OsteoFlo Synthetic Nanoputty Syringe - 10cc - IOSALSurgentec, LLCONP-S-10 - IB2025-06-10
00810131881153 OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSALSurgentec, LLC ONP-T-1000-IB2025-06-10
00810131881160 OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSALSurgentec, LLC ONP-T-1000-IB2025-06-10
00810131881177 OsteoFlo HydroPutty Synthetic HFP - 6cc Labeled - IOSALSurgentec, LLC OHFP-S-06-IB2025-06-10
00810131881184 OsteoFlo HydroPutty Synthetic HFP - 12cc Labeled - IOSALSurgentec, LLC OHFP-S-12-IB2025-06-10
00858406007648 OsteoFlo Synthetic Nanoputty Cartridge Graftgun Combo Kit - 5ccSurgentec, LLC ONP-K-5002025-06-10
00858406007655 OsteoFlo Synthetic Nanoputty Cartridge Graftgun Combo Kit - 10ccSurgentec, LLC ONP-K-10002025-06-10
00858406007662OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 1ccSurgentec, LLCONP-U-012025-06-10
00858406007679OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 2.5ccSurgentec, LLCONP-U-022025-06-10
00858406007686 OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 5ccSurgentec, LLC ONP-U-052025-06-10
00858406007693 OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 10ccSurgentec, LLC ONP-U-102025-06-10
07898315500901Bone Cement - Normal ViscosityBiomecânica Indústria e Comércio de Produtos Ortopédicos Ltda.Bone Cement - Normal Viscosity2025-04-23
00815212026966OS 11G BONE FILLER KIT-OSTEOFIXIzi Medical Products, LLCG800122025-03-26
00889095358230CONCORDGLOBUS MEDICAL, INC.4129.2020S2024-12-01
00889095358247CONCORDGLOBUS MEDICAL, INC.4129.4040S2024-12-01
08058964729033Arthrex Bone Cement HVG21 SRLAS-901-HV2024-10-04
08058964729040Arthrex Bone Cement MVG21 SRLAS-901-MV2024-10-04
08058964728647Arthrex Bone Cement HVG21 SRLAR-901-HV2024-09-16
08058964728678BRAVO HVG21 SRL611-01-0402024-09-16
08058964728739Arthrex Bone Cement MVG21 SRLAR-901-MV2024-09-16
08058964729002BRAVO MVG21 SRL610-01-0402024-09-16
04260056882579BonOs HVOSARTIS GmbH1x402024-05-17
00815212026775Vertefix MVIzi Medical Products, LLCG900062024-02-16
00815212026782Osteo-site VCF Kit, Vertefix MV CementIzi Medical Products, LLCG800092024-02-16
00815212026799Osteo-site Bone Filler Kit-MVIzi Medical Products, LLCG800102024-02-16
00815212026805Osteo-site Bone Filler Kit-MVIzi Medical Products, LLCG800112024-02-16
00850391007252Montage Settable Bone PuttyABYRX, INC.MON-BVF-16042023-11-16
00889797069298INVISION™WRIGHT MEDICAL TECHNOLOGY, INC.600060272022-11-16
00763000590970Kyphon VuE Bone Cement and Kyphon MixerMEDTRONIC SOFAMOR DANEK, INC.CT01B2022-07-25
08031497002538Kyphon VuE™ Bone Cement TECRES SPACT01A2022-05-13
00190446138037DJO SURGICALEncore Medical, L.P.600-50-0042022-05-12
00815212026362Bone Filler Kit-HV EUIzi Medical Products, LLCG80007E2022-05-04
00190446138020DJO SURGICALEncore Medical, L.P.600-30-0202022-04-26