Sirakoss Ltd. granted 510(k) FDA clearance for Osteo3 ZP Putty

First augmented reality spinal surgery using augmedics xvision spine.
This product by Sirakoss Ltd. is designed to fill gaps and voids in bone structure, and facilitate rapid regeneration of bone. Image courtesy of Sirakoss Ltd.

The FDA has granted 510(k) clearance for the Osteo3 ZP Putty from Sirakoss Ltd. Sirakoss is based out of Aberdeen, Scotland, and originated from research conducted out of the University of Aberdeen. Sirakoss produces nanosynthetic bone regeneration products, providing an alternative to other devices used in spine and trauma bone grafts.

Products such as these are most commonly used to fuse bones together to correct congenital or degenerative conditions, or after a traumatic injury causing spinal damage that does not heal. The Osteo3 ZP Putty is designed to fill gaps and voids in bone structure, and provide rapid and complete bone regeneration.

The Osteo3 ZP Putty differs from other products because it is made of synthetic granules, suspended in a synthetic carrier. In addition, it may be used more quickly and easily than other options, meaning it will save surgeons time. Patients will need to be anesthetized for shorter periods of time when this product is used, because of its fast-acting ability. These advantageous features will likely reduce costs for both the healthcare provider and patient, and create more availability in operating rooms.  

Iain Gibson, co-founder and Director of R&D at SIRAKOSS and Professor of Acellular Regenerative Medicine at Aberdeen University, explained:

“Our Osteo3 ZP Putty has demonstrated excellent pre-clinical performance in models of spinal fusion and trauma repair. Being able to provide surgeons with the synthetic bone graft in a pre-packed syringe, saves time and is far easier to handle during the procedure in the operating room environment. This product was developed with grant funding support from Innovate UK, part of the United Kingdom Research and Innovation (UKRI) organisation, and we’d like to thank them for their continued support in the development of this more advanced, next generation product.”

Via: OrthoSpineNews

For Further Information

This recent development presents interesting implications for the future of the spinal device market. To get an in-depth global (25-country) market analysis which includes in-depth interviews and procedural volumes, check out iData Research’s report titled Spinal Implants Market Analysis, Size, Trends | Global | 2019-2025 | MedSuite

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