Maxx Orthopedics announces FDA 510(k) clearance for Libertas® Bipolar Hip System

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Maxx Orthopedics announces FDA 510(k) clearance for Libertas® Bipolar Hip System

PR Newswire

NORRISTOWN, Pa., Nov. 15, 2025

This clearance further expands the company's Libertas® Hip Portfolio, which includes the Libertas® Taper Reduced (TR) Stems, Libertas® Mini TR Stems for anterior approaches, Libertas® HA Coated Stems (collared and non-collared), and Libertas® Cemented Stems. The addition of the Bipolar System strengthens Maxx Orthopedics' offering for surgeons seeking versatile and clinically proven solutions for hemiarthroplasty procedures.

NORRISTOWN, Pa., Nov. 15, 2025 /PRNewswire-PRWeb/ -- Maxx Orthopedics, Inc. (Norristown, PA.), a rapidly expanding global orthopedics device company, today announces that it has received US FDA clearance for the Libertas® Bipolar Hip System.

"Expanding our hip portfolio demonstrates our ongoing commitment to supporting surgeons with advanced implant options that address diverse patient needs, said Farzin Khaghani, Chief Commercial Officer at Maxx Orthopedics. Our focus remains on creative, affordable, reliable, and efficient solutions."

This clearance further expands the company's Libertas® Hip Portfolio, which includes the Libertas® Taper Reduced (TR) Stems, Libertas® Mini TR Stems for anterior approaches, Libertas® HA Coated Stems (collared and non-collared), and Libertas® Cemented Stems. The addition of the Bipolar System strengthens Maxx Orthopedics' offering for surgeons seeking versatile and clinically proven solutions for hemiarthroplasty procedures.

The Libertas® Bipolar System combines a cobalt-chromium (CoCr) outer shell with an ultra-high molecular weight polyethylene (UHMWPE) liner and a factory-assembled retention ring. Designed for use with 28 mm femoral heads, the system delivers a reliable, efficient, and reproducible solution for fracture management, osteonecrosis, and revision hip applications.

Key Features and Benefits:

  • 28mm Head Compatibility – Streamlined solution designed exclusively for 28 mm femoral heads, simplifying complexity in head selection and optimizing intraoperative efficiency.
  • Comprehensive Sizing – Offered in 44–60 mm diameters (1 mm increments) to accommodate a wide range of patient anatomies.
  • Proven Materials – CoCr outer shell with UHMWPE liner and retention ring deliver durability and stability.
  • Self-Aligning Design – Eccentric head geometry and preassembled liner ensure smooth articulation and a secure fit.
  • Modern Instrumentation – Includes trial heads, sizing gauges, and extraction tool in a dedicated bipolar instrument set for streamlined surgical workflow.

"We are proud to expand our hip portfolio with the FDA clearance of the Libertas® Bipolar System," said Farzin Khaghani, Chief Commercial Officer at Maxx Orthopedics. "This addition demonstrates our ongoing commitment to supporting surgeons with advanced implant options and instrumentation that address diverse patient needs. Our focus remains on innovation that drives creative, affordable, reliable, and efficient solutions."

About Maxx Orthopedics, Inc.

Maxx Orthopedics, Inc. is the manufacturer of the Freedom Knee System, Libertas Total Hip System, and Quick Recovery Solutions (QRS). We develop and market innovative orthopedic medical devices with a focus on providing state-of-the-art implants and related solutions designed to restore patient mobility, while accommodating lifestyle, anatomical and economic needs. Find out more at www.maxxortho.com/ and follow us on LinkedIn, X, Instagram, and Facebook.

Media contacts:

Maxx Orthopedics, Inc.

Donald Montgomery

info@maxxortho.com

Media Contact

Donnie Montgomery, Maxx Orthopedics, 1 4843420092, donnie.montgomery@maxxortho.com, www.maxxortho.com

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SOURCE Maxx Orthopedics