Synjectos

SYNJECTOS®​ Synthetic Bone Graft Substitute

Synjectos® develops and manufactures a Calcium Phosphate Cement designed to restore and substitute bone.

Synjectos® is used in all areas of Traumatology and Orthopaedics that deals with bone loss during surgery and/or after trauma. Typical indications are filling of bone cysts, articular depression fractures in spine and long bones or filling of defects after autologous bone harvesting.

Synjectos® is a Bone Cement all in one system, which makes the surgical procedure easier and faster.

Its customers are Orthopaedics & Traumatology surgery clinics who want as little expenditure of time and money as possible.

Used exclusively by surgeons For filling of bony defectes by standard orthopedic techniques of fracture reduction & stabilization

The Synjectos® has been developed and designed to be used in all bone defects stabilized by an appropriate surgical procedure at the fracture site, e.g. humeral head fractures, distal radius fractures, tibia head impression fractures, calcaneal fractures, filling of benign bone cysts or filling of bony defects after bone harvesting for autologous bone graft and filling of bone cavities of collapsed VB fractures such as wedge fractures (A1.1 and A1.2, A3.1 after additional surgical stabilization) after fracture reduction procedures.

Synjectos® is available in:

10 cc Syringe System

     13g Synjectos Powder

     6.5 ml Synjectos Liquid

5 cc Syringe System

     7g Synjectos Powder

    3.5 ml Synjectos Liquid

3 cc Syringe System

     4g Synjectos Powder

     1.5 ml Synjectos Liquid

To read the complete precautions, please refer to the Instructions for Use.
The product must only be handled or implanted by trained qualified physicians having read the instructions for use.

Synjectos® should be used exclusively by surgeons who are familiar with the handling of calcium phosphate cements and the corresponding surgical techniques like treatment of osseous defects.

Never use the product if the packaging is opened or defective. This may affect the functionality and especially the sterility of the material.

It is important that the user of the product is familiar with the physiopathology of the anatomical region of the implantation site.

The product was not evaluated in children or during pregnancy.

The use of Synjectos is considered for filling of bony defects which are stabilized by standard orthopedic techniques of fracture reduction and stabilization.

Before application of Synjectos excessive bleeding on the implantation site must be controlled.

The material is not allowed to be implanted in soft tissue, avascular bone, sites with predisposition for infections, like open fractures without soft tissue coverage.

Do not implant Synjectos with pressure in locations with the risk fat embolization or risk of embolization of Synjectos into blood stream.

Synjectos may not be applied into open epiphyseal aéreas.

The hardened material will reach its ultimate mechanical strength 24 hours’ after implantation; therefore, the patient should avoid active weight bearing movements for the first 24 hours after surgery.

Read the instructions for use

Not all products are registered or available in every country/region. Please check with Synjectos representative for availability and further information or Contact Us

Instructions

Step 1: Hold the syringes in a vertical position and open
the red obturator cap on both syringes.

Step 2: Fix the transparent connector onto the small syringe with a firm rotation to the right and connect the screw tip of the bigger syringe with the connector until both syringes are firmly connected.

Step 3: Slowly inject the liquid of the small syringe into the powder containing syringe by concurrently pulling back the plunger in order to avoid overpressure in the syringe.

Step 4: Disassemble the connector plus the small syringe from the bigger syringe and obturate the tip of the bigger syringe with the red obturator.

Step 5: Shake the syringe vigorously for 5 seconds until a homogenous paste has been formed.

Step 6: The paste is now ready to be injected into the defect site.

Advantages

The advantage of Synjectos® over its competitors’ products is in that powder as well as liquid is provided pre-filled in sterile syringes. The sterile liquid is transferred directly into the powder containing syringe. By avoiding open mixing no contamination by air germs and no spill of material will occur by using the advanced formulation in combination with its packaging. Also mixing mistakes caused by spill of material during transfer out of glass vials into a mixing bowl like in case of its competitors’ products will be avoided. The package concept of Synjectos® also saves resources and avoids excessive garbage in the hospital.

Important

Synjectos® must NOT BE implanted in following circumstances:
  • Acute or chronic infections on the implantation site.
  • Presence of malign tumors.
  • Presence of osseous infections and inflammations like osteomyelitis.
  • Defects in direct apposition of open epiphyseal areas.
  • Renal or severe hepatic dysfunction.
  • Treatment with immunosupressive drugs.

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