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GLW Announces Additional FDA 510(K) Clearance for the Artemis Proximal Femoral Nail System

By orthoPro


ENGLEWOOD CLIFFS, NJ, USA, October 31, 2022 / – GLW Trauma, a GLW Medical Innovation (GLW) company focused on a paradigm shift in the surgical treatment of trochanteric hip fractures, announced today an additional U.S. Food and Drug Administration (FDA) 510(k) clearance of the Artemis Proximal Femoral Long Nail System, the second intramedullary nail to be cleared as part of the Artemis PFN System.

Hip fractures represent a substantial economic burden to the U.S. healthcare system, accounting for $5.96 billion¹ of costs per year, with intertrochanteric hip fracture accounting for 44% of that total (approximately 160,000 annual procedures).  “We continue on our journey to improve hip fracture technology and care,” said Vadim Gurevich, President & CEO of GLW Medical Innovation.  “Showing value to the hospital purchasing, sourcing, and supply chain is central to our mission of bringing together manufacturing innovation with a legacy of engineering expertise.  That is why we are so excited to introduce Artemis PFN System’s complete portfolio of intramedullary short and long nails to the market.” 

The Artemis PFN System is indicated for the treatment of stable and unstable intertrochanteric fractures as well as fractures of the subtrochanteric and shaft regions of the femur. The system features:

  • Hybrid Materials and Patented Manufacturing Process: Provides the nail structural benefits with the strength of titanium and the flexibility of CFR PEEK.
  • Lagshield™ Function:  Includes a protective layer of CFR PEEK on the lateral side of the nail to help prevent the Lag Screw Reamer from notching the nail’s titanium core during the reaming procedure.
  • Enhanced Stability and Rotational Control: Consists of a Lag Screw with optional combination of integrated anti-rotational Locking Pin which supports compression and helps to eliminate the Z-effect.

GLW Trauma is currently marketing and selling the short Artemis PFN System nail and is targeting limited market release of the new long nail in the first quarter of 2023.

About GLW Medical Innovation
GLW is a medical technology company that uses its proprietary ortholucent technology platform to develop, additive manufacture, and sell orthopedic extremity and trauma implants and instruments. GLW owns issued patents and pending patent applications that cover hybrid materials and cost-effective manufacturing.