On November 1, 2019, Stryker announced that its 3D printed laterally scalable implants have obtained FDA 510K certification.
Stryker has announced its FDA 510K approval for its 3D printed SAHARA laterally scalable human system.
The laterally scalable fusion implant relies on its layered titanium 3D technology and was developed by medical device company K2M acquired by Stryker last year. With its passive expansion function, surgeons can achieve up to 30 degrees of spinal correction in patients with mature bones.
Layered titanium 3D technology can create structures that were previously impossible to achieve using traditional methods. High-energy laser beam selective sintering (SLM technology) titanium powder prints out SAHARA implants and retains the rough surface structure. Clinical trials have shown that rough surfaces can increase protein expression compared to smooth titanium surfaces.
Stryker will present its latest 3D printed implants at the Society of Minimally Invasive Spine Surgery (SMISS) this week.
Eric Major, president of Stryker ’s spine department, commented: “At Stryker, we invented the most advanced solutions in the country. Solving unmet clinical needs is our vision and purpose. SAHARA Lateral will be at this year`s SMISS Annual Forum On display, it provides 3D printing solutions for surgeons and hospital systems for corrective surgery of complex spinal deformities, while strengthening our commitment to medical innovation and people who improve the quality of life. "
According to SmarTech's forecast, the global 3D printing medical market reached US $ 1.229 billion in 2016, of which the market for 3D printing implants reached US $ 823 million; the medical market for 3D printing implants reached US $ 9.639 billion in 2024, of which 3D printing The size of the input market reached 8.12 billion US dollars. In the global market, 9 companies including Depuy, Stryker, Zimmer, Synthes and other orthopedic implant brands account for 80% of the total orthopedic implant market.
On March 9, 2018, Stryker's 3D printed Tritanium (titanium alloy) TL curved lumbar spine was approved by the US Food and Drug Administration (FDA) 510 (k). This is a 3D printed interbody fusion cage for lumbar fixation. The hollow implant consists of a unique configuration of solid and porous structures, both of which are 3D printed using Stryker's proprietary additive manufacturing process, AMagine, for implant production.
On September 3, 2018, Virginia medical device manufacturer K2M will be acquired by Stryker Corporation, a US Fortune 500 medical technology company. The acquisition amount reached 1.4 billion US dollars (approximately 9.5 billion RMB). K2M has a variety of FDA-approved 3D printed implants. In 2016, the company's two 3D printed spine solutions-CASCADIA Cervical (cervical spine) and CASCADIA AN Lordotic Oblique (anterior oblique) obtained the US Food and Drug Administration (FDA) sales license. In 2017 they had another new product for spine support — MOJAVE PL — which was approved by the US Food and Drug Administration (FDA).
Stryker Corporation (Stryker Corporation) was founded in 1941, is one of the world's largest orthopedics and medical technology companies, headquartered in Klamathu, Michigan, USA, has 14 production R & D and sales branches worldwide, employees More than 16,000 people.
Products include joint replacement, trauma, craniofacial, spine, surgical equipment, neurosurgery, otolaryngology, interventional pain management, minimally invasive surgery, navigation surgery, intelligent operating room and network communication, biotechnology, medical bed, emergency push bed Wait.
In 2016, the orthopedics business revenue was 5.176 billion US dollars (orthopedics + spine), ranking third in the global orthopedics field.
Because of its good performance, Stryker was named one of the Fortune 500 companies and one of the top 50 medical companies in the United States by the well-known Fortune magazine and Business Week in the United States.
Stryker has a very good clinical reputation in the Chinese market. In recent years, Stryker has also been extremely active in the global capital market. Through continuous acquisition of medical device manufacturing companies, expanding its product market share and product line is also a good prospect for the future of the global medical device market.