Regulatory

FDA Grants 510(k) Clearance to Zimmer Biomet’s G7 Acetabular System

The system is compatible with multiple G7 liners, including Dual Mobility and Freedom Constrained.

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By: Michael Barbella

Managing Editor

The G7 Acetabular System, featuring Rim Fix Screws and perimeter holes that provide multiple points of access and engagement. Photo: Zimmer Biomet Holdings Inc.

Zimmer Biomet Holdings Inc. has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for its G7 Acetabular System, a next-generation implant engineered to address challenging primary and revision hip replacement surgeries.

Built on Zimmer Biomet’s G7 platform, 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.

“FDA clearance of the G7 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.”

Designed for Challenging Primary and Revision Cases

  • Trabecular Metal Technology: The G7 shell’s Trabecular Metal 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 various orthopedic applications.1-5
  • Anatomically Derived Screw Hole Pattern: The G7 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.
  • Rim Fix Screws: G7 shells incorporate perimeter screw holes located within 5 mm 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.6
  • G7 System Compatibility: The system is compatible with multiple G7 liners—including Dual Mobility and Freedom Constrained—offering the same versatility to establish a stable joint in total hip arthroplasty.

Zimmer Biomet will now begin to market the G7 Acetabular System in the United States, supported by surgeon education and training programs, with a 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.

Zimmer Biomet’s product portfolio is designed to maximize mobility and improve health. It solutions seamlessly transform the patient experience through integrated digital and robotic technologies that leverage data, data analytics, and artificial intelligence. Founded more than 90 years ago, the company maintains operations in over 25 countries and sales in 100-plus countries.

References
1 Bobyn JD. et al. Characterization of new porous tantalum biomaterial for reconstructive orthopaedics. AAOS 66th Annual Meeting; 1999; Anaheim, CA.
2 Karageorgiou V, Kaplan D. Porosity of biomaterial scaffolds and osteogenesis. Biomaterials. 2005;26:5474–5491.
3 Bobyn JD. et al. Characterization of new porous tantalum biomaterial for reconstructive orthopaedics. AAOS 66th Annual Meeting; 1999; Anaheim, CA.
4 Karageorgiou V, Kaplan D. Porosity of biomaterial scaffolds and osteogenesis. Biomaterials. 2005;26:5474–5491.
5 Zhang Y. et al. Interfacial frictional behavior of bone and porous tantalum. J Musculoskelet Res. 1999.
6 G7 Revision Micromotion Verification (Zimmer Biomet, data on file, 2025).

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