Research & Development
Maxx Orthopedics Receives FDA 510(k) Clearance for Its Libertas® Bipolar Hip System
17 November 2025 -

* Maxx Orthopedics has announced the latest addition to its expanding Libertas® Hip Portfolio, securing FDA 510(k) clearance for the Libertas® Bipolar Hip System. This development further broadens the company's suite of hip solutions, which already features the Libertas® Taper Reduced (TR) Stems, Libertas® Mini TR Stems designed for anterior approaches, Libertas® HA Coated Stems available in collared and non-collared options, and the Libertas® Cemented Stems. The newly cleared Bipolar System enhances the offering available to surgeons looking for flexible, clinically validated options for hemiarthroplasty procedures.

NORRISTOWN, Pa. -- Maxx Orthopedics, Inc., a fast-growing global medical device manufacturer based in Norristown, Pennsylvania, has confirmed US FDA clearance for the Libertas® Bipolar Hip System.

The approval marks another significant milestone for the company, expanding the established Libertas® Hip Portfolio and reinforcing its commitment to delivering innovative and reliable solutions for orthopaedic surgeons. With the addition of the Bipolar System, Maxx Orthopedics strengthens its position as a provider of comprehensive hip reconstruction technologies aimed at improving clinical outcomes in hemiarthroplasty.

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."

source:newsreleases.co.uk

Login
Username:

Password: