G21 S.R.L.

G21 S.R.L. specializes in orthopedic and spinal surgical devices. Their portfolio includes bone cement formulations (such as G1 40, G3 40, and G3A 40), kyphoplasty balloon catheters (e.g., Winch Kyphoplasty 11G 20mm), bone cement filler cannulas (like KeyFix), and modular joint implants such as the SpaceFix Shoulder Spacer and SpaceFlex Knee (80mm). They also produce surgical tools like the V-MIX 02 mixer and stabilization systems like V-STEADY and V-FAST. These devices are designed for vertebral consolidation and articular functional rehabilitation.

G21 S.R.L. is based in Italy. Their devices are registered in the EU’s eudamed database, which tracks medical devices authorized under EU regulations. Additionally, their products are listed in the FDA’s 510(k) registry, indicating compliance with U.S. premarket notification requirements for certain device types. These registries reflect the company’s global presence and adherence to regulatory transparency.

Under EU regulations, G21 S.R.L.’s devices span multiple risk classes: Class I (low-risk, non-invasive), Class IIa (moderate-risk, e.g., some surgical tools), Class IIb (higher-risk, e.g., kyphoplasty catheters), and Class III (highest-risk, e.g., life-supporting implants like the SpaceFlex Acetabular Cup). In the U.S., relevant devices are submitted via the 510(k) pathway, demonstrating substantial equivalence to predicate devices. Classification depends on risk, intended use, and interaction with the body.

Yes, G21 S.R.L.’s devices address both spinal and joint applications. For spinal procedures, they offer kyphoplasty catheters (e.g., Winch) and bone cements (e.g., G3 40) for vertebral consolidation. For joint surgeries, their portfolio includes modular implants like the SpaceFix Shoulder Spacer and SpaceFlex Knee (80mm), as well as acetabular cups (e.g., SpaceFlex Acetabular Cup) for hip replacements. The company’s solutions are tailored to both vertebral stabilization and articular functional rehabilitation.