Becker's Spine Review

46 DEVICES & IMPLANTS NuVasive's Porous PEEK material yields positive results after impaction: 5 insights By Megan Wood A new study published in The Spine Journal com- pared NuVasive Porous PEEK material to titani- um-coated PEEK devices. Researchers assessed the ability of titanium-coated PEEK, smooth PEEK and NuVasive Porous PEEK to han- dle impaction loading conditions. Here are five insights. 1. The NuVasive Porous PEEK's surface structure kept its high porosity of more than 65 percent, with only minor changes to pore size and depth after impaction. 2. The smooth PEEK devices also showed little damage but experienced a decrease in surface roughness. 3. The study revealed the titanium-coated PEEK devices lost titanium coating following impaction and experi- enced a decrease in surface roughness. 4. NuVasive develops its Porous PEEK products via a proprietary extrusion process, creating a porous-to-sol- id structure. The structures are intended to boost osse- ointegration and bone-to-implant contact. 5. The company offers Cohere and Coalesce Interbody Fusion Devices for cervical and thoracolumbar proce- dures. n 15 orthopedic, spine device companies that may be affected by Trump's 25% tariff proposal By Mackenzie Garrity P resident Donald Trump recently proposed a 25 percent tariff on a list of products from China. Some of the items on the list include magnetic resonance imaging electro-diagnostic appara- tuses, orthopedic or fracture appliances and artificial joints. e statement from the Office of the U.S. Trade Representative published by e Wall Street Journal, said the reason for the tariff is due to "the acts, policies and practices of the government of China related to technology transfer, intellectual property and innovation covered in the investigation are unreasonable or discriminatory and burden or restrict U.S. commerce." Orthopedic and spine companies are among those who could be affect- ed by the proposed tariff. While not all companies are based in China, many have distribution and manufacturing agreements. Here are 15 companies who may face burdens from the proposal. Alphatec (Carlsbad, Calif.). e medical device company is part- nered with independent distributor Scient'x's which distributes Al- phatec's implants and instruments throughout China. Arthrex (Naples, Fla.). While Arthrex is expanding in the U.S., the medical device company also has a corporate manufacturing center in Shanghai, China. DePuy Synthes (Warsaw, Ind.). In 2008, DePuy Synthes opened a state-of-the-art manufacturing plant in Suzhou, China, to distribute implants and instruments throughout the country. Exactech (Gainesville, Fla.). While having a corporate manufactur- ing location in Shanghai, Exactech distributes its hip and knee systems throughout the country. Globus Medical (Audubon, Pa.). Globus Medical acquired Alphatec, which distributes implants and instruments throughout China. Life Spine (Huntley, Ill.). In early 2014, Life Spine entered into a part- nership with China Pioneer Pharma Holdings to grow its orthopedic market share in China. Mazor Robotics (Caesarea, Israel). Mazor Robotics partners with Chi- nese distributor Cicel Science. Additionally, the Renaissance robotic sys- tem was recently awarded China Food and Drug Administration approval. NuVasive (San Diego). Since NuVasive named Gregory Lucier CEO, the company has been working on expanding into the greater Chinese market for orthopedics. Orthofix (Lewisville, Texas). An Orthofix distribution center for ex- ternal and internal fixation systems is located in Shanghai. OrthoPediatrics (Warsaw, Ind.). OrthoPediatrics partnered with Bio- retec, a Chinese device company, to distribute the company's implants and systems. Smith & Nephew (London, England). e company has manufactur- ing facilities in mainland China and Hong Kong. SpineGuard (Saint-Mandé, France). In 2017, SpineGuard part- nered with Xing Rong Medical Group in China to distribute the com- pany's implants. Later in the year, Xing Rong Medical announced it began purchasing SpineGuard's PediGuard system. Stryker (Kalamazoo, Mich.). Stryker has manufacturing locations all throughout China, including Beijing, Chengdu, Guangzhou, Hong Kong, Shanghai and Wuhan. United Orthopedic Corporation (Irvine, Calif.). United Orthopedic Corporation was first established in China beforing brining its opera- tions to the U.S. five years ago. e medical device company has loca- tions in Taiwan and China. Zimmer Biomet (Warsaw, Ind.). Zimmer Biomet's has a manufactur- ing location in China for the company's orthopedics and microfixa- tion devices. Recently, the FDA lied its warning letter on the Zimmer Biomet's China plant. n

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