ConforMIS Gets FDA Approval for iTotal Hip System

ConforMIS (NASDAQ:CFMS) has announced the receipt of FDA 510(k) clearance for its primary iTotal hip replacement system.
As quoted in the news article:

The ConforMIS iTotal Hip system features proprietary iFit image-to-implant technology. The system utilizes the company’s patient-specific technology and single-use 3D printed instruments. The iTotal Hip system is expected to be launched in 2019.
Per management, standard hip replacement surgery involves challenges and risk of dislocation and discrepancies in leg length. The ConforMIS iTotal Hip system is designed to overcome these challenges and risks and improve outcomes as this is designed to match a patient’s anatomy. This product will expand the company’s product portfolio to address a broader orthopedic market.
We are bullish on the ConforMIS’ focus on the rapidly growing hip replacement market. Approximately 400,000 hip replacements were performed in the domestic market in 2016.
According to Data Bridge Market Research , the global hip replacement implants market is expected to reach a worth of $7.1 billion by 2024 at a CAGR of 3.6% during the 2017 to 2024 period.So, the company clearly has bountiful opportunities in this niche market.
According to a study of HealthDay over 10 years from 2000 to 2010, the number of hip replacements has sky rocketed from 138,700 in 2000 to 310,800 in 2010. So the company, in line with its peers Inogen, Inc. INGN , Luminex Corporation LMNX and Accelerate Diagnostics, Inc. AXDX , are taking strategic steps to gain traction in the untapped market.

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