Kelyniam Global has received FDA clearance for its Fusion brand of cranial and craniofacial implants, the first new product of its kind in eight years.
The implants are made from a combination of biphasic calcium phosphate with polyether ether ketone, and is designed to help bone grow into the implant, according to a Sept. 18 news release.
Kelyniam said the implants can be designed and shipped to surgeons within 24 to 48 hours, helping patients who need surgery after trauma, tumor removal or congenital skull conditions. The product adds to the company’s regenerative implant line, which also includes hydroxyapatite and Osteopore brand implants.
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