Issue link: https://beckershealthcare.uberflip.com/i/883254
37 DEVICES & IMPLANTS K2M unveiled its SAHARA AL Expandable Stabilization Sys- tem. Pittsburgh-based Allegheny General Hospital joined InVivo erapeutics' INSPIRE study. SpineGuard announced its exclusive distribution agreement with XinRong Medical Group for PediGuard in China, Hong Kong and Macau. DePuy Synthes launched its Distal Radius Sterile Kit, a pre-sterilized, single-use kit of instruments and implants to treat wrist fractures. e FDA granted approval for ConforMIS' iTotal Hip system. Zyga Technologies obtained a patent updating the company's SImmetry Decorticator. Nuvectra filed a regulatory submission with the FDA for full- body MRI-conditional approval for its Algovita SCS system. Camber Spine Technologies named Grant Newsom and Doug Wyciskalla new area sales directors. e Medicrea Group earned FDA clearance for its UNiD HUB. e Medicrea Group showcased its UNiD ASI technology for Adaptive Spine Intelligence at the State of Spine Surgery ink Tank in Los Cabos, Mexico, from June 15 to June 17. n FDA Approves ConforMIS iTotal Hip Replacement System: 5 Takeaways By Mackenzie Garrity C onforMIS received FDA clearance for its iTotal Hip replacement system set to launch in 2019, according to a Zacks report. Here are five takeaways: 1. The ConforMIS iTotal system uses iFit image-to-implant tech- nology and single-use 3D printed instruments. 2. This system is designed to overcome dislocation and dis- crepancies in leg length, which are current challenges and risks of hip replacement surgery. 3. In 2016, approximately 400,000 hip replacements were per- formed. 4. According to Date Bridge Market Research, the global hip replacement implants market is expected to reach $7.1 billion by 2024. 5. ConforMIS uses iFit image-to-implant technology to devel- op, manufacture and sell joint replacement implants that are customized to each patient. n Jana Receives Clearance to Purchase Additional Zimmer Biomet Shares: 5 Things to Know By Laura Dyrda T he U.S. Federal Trade Commission granted Jana Partners clearance that would allow the hedge fund to purchase additional stake in Zimmer Biomet, according to Reuters. Here are five key notes: 1. Zimmer Biomet's longtime CEO David Dvor- ak stepped down on July 11 and the company's CFO stepped in as interim CEO while the company conducts a nationwide search for Mr. Dvorak's replacement. 2. According to Reuters, Jana is positioning itself to "build its stake and press for changes at the company." Jana's cur- rent stake in Zimmer Biomet is not clear, and Zimmer Biom- et did not comment on the news. 3. Since Mr. Dvorak stepped down, Zimmer Biomet's shares have lost two-thirds of their value, according to the report. 4. Bloomberg News reported Jana has talked with Zimmer Biomet about potential changes. 5. On the same day Mr. Dvorak stepped down, Zimmer Biom- et released a preliminary financial report for the second quar- ter of 2017. Interim CEO Dan Florin said "certain brands did not achieve targeted production levels as quickly as we antic- ipated" after Zimmer's merger with Biomet, and the company has been slower than expected at recapturing expected sales from customers impacted by the production lag. "As we look toward the second half of 2017, we are focused on restoring full product supply and improving customer engagement, while continuing to progress on our quality enhancement efforts," said Mr. Florin. n