G3A 40 Bone Cement

Trade Name

G3A 40 EUDAMED

G3A 40 Bone Cement GUDID

Generic Name

Orthopaedic cement, antimicrobial

Model / Reference

800009

FDA applicant

G21, S.R.L.

Primary DI / UDI-DI

08058964720122

Basic UDI-DI

B-08058964720122

510(k) Number

K181282 ↗

FDA Product Code

LOD, MBB

EMDN Code

P099001 Orthopaedic prostheses cements and accessories for mixing

GMDN Term

Orthopaedic cement, antimicrobial

Device Class

Class III EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 888.3027

Market of Registration

Bulgaria

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

Commercial Distribution

In Commercial Distribution

• V-Mix 02

  Class I

  CE/MDR

• SpaceFlex Hip Instrument Kit

  Class I

  CE/MDR GUDID on market

• SpaceFlex Knee 80mm

  Class II

  CE/MDD FDA 510(k) K201960 Active Cleared 13 Aug 2020

• SpaceFix Shoulder Spacer

  Class II

  CE/MDD FDA 510(k) K252443 Active Cleared 15 Sep 2025

• V-Steady, V-Fast Bone Cement

  Class II

  CE/MDD FDA 510(k) K150408 Active Cleared 14 Dec 2015

• G3 40 Radiopaque Bone Cement

  Class II

  CE/MDD FDA 510(k) K193061 Active Cleared 19 Mar 2020

See all devices from G21 S.R.L. →

• What types of joint replacement surgeries is the G3A 40 Bone Cement specifically designed for, and how does it contribute to the procedure?

  The G3A 40 Bone Cement is designed for surgical fixation in arthroplasty procedures, specifically stabilizing bone-prosthetic interfaces during joint replacements. It is used in hip, knee, ankle, and shoulder arthroplasties, acting as an adhesive and filling material to ensure mechanical stability and biocompatibility with living bone tissue.

• Is the G3A 40 Bone Cement reusable, and if not, how should it be handled to maintain its properties?

  The G3A 40 Bone Cement is supplied as a sterile, single-use product for intraoperative use only. While it is technically reusable under sterile conditions, it must be handled strictly according to manufacturer guidelines to preserve its radiopacity and mechanical integrity. Reuse requires careful sterilization and adherence to controlled surgical protocols.

• How should the G3A 40 Bone Cement be stored, and are there any special considerations for its compatibility with MRI environments?

  Storage and handling instructions must be followed to preserve the G3A 40 Bone Cement’s properties. While the data does not specify exact storage conditions, radiopacity is a key feature, so it should be stored in a way that prevents contamination or degradation. Before use in MRI environments, compatibility must be confirmed with the manufacturer, as some bone cements may interfere with imaging.

• What regulatory pathways has the G3A 40 Bone Cement followed, and what does this mean for its use in clinical settings?

  The G3A 40 Bone Cement has undergone FDA 510(k) clearance under the Traditional pathway and complies with the Medical Device Directive (MDD). This means it has been evaluated for substantial equivalence to a predicate device and meets EU safety, performance, and quality standards. Clinicians can rely on its regulatory approvals as part of their decision-making for orthopedic procedures.