OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Ogm®

Ogm® 1

Ogm® 1A

Device Name

OGM Knee Spacer With Gentamicin 56

OGM Knee Spacer With Gentamicin 86

OGM Orthopedic Sterile Tourniquet – XSMALL

OGM Hip Spacer With Gentamicin Short (φ 56)

Ogm Vtb Kit -- Vertebroplasty Bone Intervention Kit First Entry Needle

OGM Orthopedic Sterile Tourniquet – XXLARGE

OGM1 Standard Viscosity Bone Cement 40 g

OGM Hip Spacer With Gentamicin Long (φ 52)

Ogm Bone Intervention Kit First Entry Needle

OGM Vertebroplasty Bone Cement 12.5 g

OGM1 Standard Viscosity Bone Cement 60 g

OGM1A Standard Viscosity Bone Cement With Gentamicin 40 g

OGM Orthopedic Sterile Tourniquet- MEDIUM

OGM1 Standard Viscosity Bone Cement 20 g

OGM Hip Spacer With Gentamicin Short (φ 60)

Ogm Working Cannula

OGM Vertebroplasty Bone Cement 20 g

OGM Vertebroplasty Bone Cement 15 g

OGM Orthopedic Sterile Tourniquet – LARGE

OGM Mix Cement Mixing Kit with Pressure

OGM Orthopedic Sterile Tourniquet – XLARGE

OGM Knee Spacer With Gentamicin 66

Model / Reference

OGMKS56/G, OGMKS86/G, TRN150654, OGMHS56/G, VTBK290321, TRN150659, 1201/S, OGMHS52L/G, KFP290324, 0308/VTB, 1881/S, 1711/SG, TRN150656, 1012/S, OGMHS60/G, KFP290322, 2071/VTB, 2023/VTB, TRN150657, MIX180122, TRN150658, OGMKS66/G

Primary DI / UDI-DI

08682024000239, 08682024000260, 08682024000369, 08682024000178, 08682024000420, 08682024000505, 08682024000055, 08682024000208, 08682024000451, 08682024000147, 08682024000093, 08682024000079, 08682024000383, 08682024000017, 08682024000185, 08682024000437, 08682024000291, 08682024000284, 08682024000390, 08682024000345, 08682024000406, 08682024000246

Basic UDI-DI

B-08682024000239, B-08682024000260, 8682024TRN1506546F, B-08682024000178, 8682024VTBK290321S6, 8682024TRN1506596R, B-08682024000055, B-08682024000208, 8682024KFP290324SU, B-08682024000147, B-08682024000093, B-08682024000079, 8682024TRN1506566K, B-08682024000017, B-08682024000185, 8682024KFP290322SQ, B-08682024000291, B-08682024000284, 8682024TRN1506576M, 8682024MIX180122Z5, 8682024TRN1506586P, B-08682024000246

510(k) Number

K211869 ↗

FDA Product Code

LOD

EMDN Code

P090908, V9003, P090805, P099002, P099001, P900403

Device Class

Class III EUDAMED

Class I EUDAMED

Class IIa EUDAMED

Class IIb EUDAMED

Class II 510(k)

Regulation

21 CFR Part 888.3027

EU market of registration

Türkiye

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• What types of orthopedic procedures are the OGM 1 and OGM 1A bone cements primarily intended for?

  The OGM 1 and OGM 1A Polymethylmethacrylate (PMMA) bone cements are designed for fixation of bone fractures and arthroplasty procedures. They provide mechanical stability and secure anchoring for implants or stabilization of fractured bone segments, making them suitable for surgeries where precise fixation is required, such as joint replacements or fracture repairs.

• Are the OGM 1 and OGM 1A bone cements single-use or reusable, and how are they supplied?

  The OGM 1 and OGM 1A bone cements are supplied as sterile, ready-to-use kits intended exclusively for single-use applications in clinical settings. Each kit is packaged to maintain sterility until immediate preoperative use, ensuring safety and compliance with medical standards.

• What regulatory pathways have the OGM 1 and OGM 1A bone cements undergone, and where are they authorized for use?

  The OGM 1 and OGM 1A bone cements have received FDA 510(k) clearance, indicating they are deemed substantially equivalent to a legally marketed predicate device. They also comply with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR) in Europe, allowing their use in both the U.S. and the EU under these regulatory frameworks.

• How quickly does the OGM 1 or OGM 1A bone cement harden after mixing, and what does this imply for surgical timing?

  The OGM 1 and OGM 1A bone cements are formulated to harden rapidly upon mixing, creating a rigid matrix that securely fixes implants or stabilizes fractures. This rapid hardening ensures quick surgical stabilization, which is critical for maintaining procedural efficiency and patient outcomes during orthopedic surgeries.

• Can you clarify the classification of these bone cements under FDA regulations and their intended medical specialty?

  Under FDA regulations, the OGM 1 and OGM 1A bone cements are classified as Class II medical devices, indicating a moderate level of risk that requires special controls to ensure their safety and effectiveness. Their intended medical specialty is orthopedics, as specified in the regulatory submissions, focusing on procedures requiring precise bone fixation.