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

By orthoPro

NEW LONG NAIL TO STRENGTHEN THE ARTEMIS PFN SYSTEM AND STREAMLINE WORKFLOWS

Englewood Cliffs, NJ – GLW, Inc. (“GLW Medical” or the “Company”), a medical technology company focused on advancing orthopedic extremity and trauma surgery, today announced additional U.S. Food and Drug Administration (FDA) 510(k) clearance of the Artemis Proximal Femoral Long Nail (PFN) 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.  “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 Medical 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.

¹ https://pubmed.ncbi.nlm.nih.gov/31161153/


ABOUT GLW MEDICAL
GLW Medical is a medical technology company focused on advancing orthopedic extremity and trauma surgery. By combining traditional and minimally invasive techniques with advanced manufacturing, including 3D printing and proprietary ortholucent technology, GLW Medical develops implants and instruments intended to support surgical efficiency and facilitate patient recovery.