g21-products-Orthopedic-SpaceFlex-modular-spacers-US

G21 designs and manufactures high quality, customer-driven cement spacer molds for knee and hip. The modular design of our spacers offers the surgeon a range of options, and the patient an increased mobility.
SpaceFlex is the new solution for the treatment of periprosthetic infection that allows the creation of a modular spacer with G21 antibiotic-loaded bone cement for arthroplasty revision in the operating room.

SpaceFlex uses an innovative method to help the treatment of periprosthetic infection by combining the reliability and safety of a preformed spacer with the versatility of a spacer made during surgery.

EASY AND FAST TO CREATE. The spacer is ready in 15 minutes, thanks to easy-to-use instrument kits.
MODULAR. The surgeon can decide the sizes during the surgery based on patient anatomy.
RELIABLE. Excellent mechanical properties comparable to preformed spacers.

SPACEFLEX HIP

SpaceFlex Hip is composed by a simple reusable instrument kit and a disposable sterile modular blister with a metal stem as core reinforcement.
Its modularity allows the surgeon to create an antibiotic-loaded bone cement hip spacer choosing among 36 different combinations of dimensions, deciding:

  • the stem diameter (10, 13, 15 mm) when ordering the SpaceFlex Hip;
  • the head diameter (48, 52, 56, 60 mm) and the stem length (140, 170, 210 mm) during the surgery.
HOW TO ORDER

The SpaceFlex Hip code is:

Code

Description

900005 xx

SpaceFlex Hip, where xx is the stem diameter to choose (10, 13, 15 mm)

Certifications:

K192041

The SpaceFlex Instruments Kit for hip code is:

Code

Description

900008

The SpaceFlex Instruments Kit for hip

Certifications:

K192041

SPACEFLEX KNEE

Two disposable sterile blisters for tibia and femur compose SpaceFlex Knee.
The SpaceFlex Knee offers the surgeon the possibility to decide the width of the femoral mold and the tibial mold thickness, based on the patient’s anatomy, choosing among the sizing options:

  • the femoral width mold size (60, 70 mm) when ordering the SpaceFlex Knee;
  • the tibial plate mold thickness (12, 16, 20 mm) during the surgery.
HOW TO ORDER

The SpaceFlex Knee code is:

Code

Description

900031 xx

SpaceFlex Knee, where xx is the femoral mold size to choose (60, 70 mm).

Certifications:

FDA 510(k): K190216