FLEX BEADS

CALCIUM SULFATE

BEADS FOR BONE INFECTION

The fully resorbable nature aligns with providing infection-related solutions, reducing complications, and promoting better long-term outcomes.

INCIDENCE OF MICROORGANISMS CAUSING SSI

Identifying the microorganisms responsible for Surgical Site Infections (SSI) to select the most suitable antibiotics and treatment approaches.

HIP REPLACEMENT

4,3%
Gram Positive

43,5%
Gram Negative

39,1%
Gram Positive/Gram Negative

13%
Other

PRODUCT OVERVIEW

G21’s latest product, Flex Beads, is designed to meet surgeons’ needs for effective bone void filling, emphasizing ease of use is crucial for surgical efficiency.
Noteworthy for being a 100% synthetic bone void filler, Flex Beads utilize synthetic calcium sulfate for controlled resorption, enabling gradual replacement by the patient’s natural bone.

FEATURES AND BENEFITS

BEADS FOR BONE INFECTION

May be used in an infected site.

BEAD SIZES

3mm
4.5mm
6mm

BEAD PREPARATION

MIX, MOLD and DELIVER: versatile solutions that can be mixed in the OR with the unique packaging, providing a quick and efficient solution.

RAPID CURE

The product’s easy-to-mix formulation and uniform fast setting time for all bead sizes (4-5min for all the three bead sizes).

SYNTHETIC CALCIUM SULFATE

No impurities, pure synthetic material.

BIOABSORBABLE BEADS

Can be placed directly into infected and noninfected bone voids and defects.

BIODEGRADABLE AND BIOCOMPATIBLE BEADS

The synthetic composition minimizes the risk of infections or reactions associated with natural materials.

RADIOPAQUE

Visible on X-ray, allow to precisely track their location, monitor the progress of a treatment, and assess the outcomes of a procedure.

ADVANTAGES IN THE APPLICATION

Choosing an innovative void management device is key to:

Minimizing avoidable complications
Improving outcomes
Reducing costs

BEAD PREPARATION

Flex Beads bone void filler kit is provided sterile for single patient use.

The Flex Beads kit contains:

Calcium sulfate powder and liquid mixing solution in pre-measured quantities
A sterile mixing bowl
A spatula
A bead mat mold

When the measured quantities are mixed, the result is a paste which may be gently packed, as molded beads, into bony voids or gaps of the skeletal system. The mixture sets to form a solid calcium sulfate implantable medical device.

PREPARATION PHASES

PHASE 1

Prepare the implant site by removing blood clots and tissue debris with the use of pulsatile lavage and suction.

Focus on two hands that open the calcium sulfate powder

PHASE 2

Open the calcium sulfate powder vial and empty contents into the sterile mixing bowl provided. Gently tap the vial to ensure maximum transfer of powder.

Focus on two hands that open the liquid vial

PHASE 3

Open the liquid vial and empty contents into the sterile mixing bowl around the periphery and edge of the bowl incorporating liquid with the calcium sulfate powder.
Gently tap the vial to ensure maximum transfer of liquid.

Focus on two hands that mix the powder and liquid together

PHASE 4 - MIXING*

Using the pestle on the long end of the provided spatula, mix the powder and liquid together in a circular motion for approximately 60 seconds or until an even and smooth mixture is achieved. The objective is to completely wet the powder with liquid to ensure a proper mix.

*Proper eye protection and surgical gloves must be worn when mixing Flex Beads
*During the mixing process material may collect on the spatula. This material must be reincorporated into the mixing process to ensure a proper mix of components.

Focus on two hands that use the wide end of the spatula to scoop and load from the Mixing Bowl

PHASE 5 - TRANSFER

Use the wide end of the spatula to scoop and load from the Mixing Bowl and into the Bead Mold Mat, provided by the kit.

Focus on two hands that use the long axis of the spatula to spread the paste

PHASE 6

3, 4.5 and 6 mm beads size can be created based on surgeon’s preference, Once it’s decided the size of the flex beads, choose on which side of the Bead Mold Mat to apply the paste.
Use the long axis of the spatula to spread the paste into the Bead Mold Mat.

Focus on two hands that gently tap the Bead Mold Mat onto the table

PHASE 7

Gently tap the Bead Mold Mat onto the table a few times to make sure proper filling of individual wells.

Focus on two hands that allow a minimum of four/five minutes

PHASE 8 - SET

Allow a minimum of four/five minutes for Flex Beads to be cured in the Bead Mold Mat.

Focus on two hands that gently flex the Bead Mold Mat

PHASE 9 - REMOVE

Gently flex the Bead Mold Mat to release the beads in the sterile field.