Zimmer Biomet Earns 510(k) for G7 TM Acetabular System

Zimmer Biomet received FDA 510(k) clearance to market the G7 TM Acetabular System, a next-generation implant engineered to address challenging primary and revision hip replacement surgeries.

U.S. commercialization is commencing, with full commercial launch expected by the end of the first quarter. The system is also compatible with Zimmer Biomet’s broader revision portfolio, including solutions for complex acetabular and femoral reconstruction.

The new system combines Trabecular Metal Technology with an anatomic screw-hole pattern, featuring Rim Fix Screws and perimeter holes designed to provide multiple points of access and engagement to help surgeons achieve stable fixation in compromised bone.

Designed for challenging primary and revision cases:

• The porous surface is made from elemental tantalum with structural, functional and physiological properties similar to bone. The material features a 100% open, engineered and interconnected pore structure to support biological fixation and vascularization with more than 20 years of documented clinical history in a wide variety of orthopedic applications.
• The shell incorporates strategically placed anatomic dome screw holes that directly align with patient anatomy to maximize shell fixation. The placement of the holes was guided by Zimmer Biomet’s custom anatomical modeling system, ZiBRA, which uses a large database of 3D-reconstructed bone scans, both male and female, representing a diverse global population.
• G7 TM shells incorporate perimeter screw holes located within 5mm of the shell rim to facilitate Rim Fix screw placement in the ischium and superior ramus of the pubis. Preclinical testing demonstrated the addition of Rim Fix screws, in conjunction with dome screws, reduced micromotion and aided in increased initial construct stability.
• The system is compatible with multiple G7 liners — including Dual Mobility and Freedom Constrained — offering the same proven versatility to establish a stable joint in total hip arthroplasty.

“FDA clearance of the G7 TM Acetabular System marks an important milestone for our hip portfolio and our commitment to advancing solutions for complex procedures,” said Lou Galrao, President of Reconstruction at Zimmer Biomet. “By integrating Trabecular Metal Technology with anatomic screw holes and Rim Fix Screws, we’re delivering a system designed to help surgeons address difficult cases while maintaining compatibility with the full G7 ecosystem.”

Source: Zimmer Biomet