FDA OKs Kelyniam’s Fusion BCP-PEEK Custom Cranial, Craniofacial Implant

Kelyniam Global, a provider of custom cranial and craniofacial implants, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Fusion BCP-PEEK cranial and craniofacial implants.

The implants are manufactured from a combination of biphasic calcium phosphate (BCP) reinforced with polyetheretherketone (PEEK). This marks the first time the FDA has approved this material for use in cranial and craniofacial implants.

The Fusion BCP-PEEK implant, according to the company, is the first new implant launched in the cranial and craniofacial market in eight years.

“Kelyniam’s achievement as the first company in the U.S. to gain FDA clearance for Fusion BCP-PEEK implants highlights our innovative spirit and dedication to advancing medical device technology,” said Desiree Webb, the company’s chief operating and revenue officer. “Kelyniam’s Fusion BCP-PEEK implants are designed to encourage bone integration while providing exceptional durability and personalized fit, reinforcing our leadership in regenerative implant solutions.”

The company said the BCP-PEEK material meets critical neurosurgery needs where patient-specific solutions are crucial to treat traumatic injuries, defects from tumor resections, or congenital anomalies. The implants can be designed, manufactured, and shipped to surgeons in 24-48 hours.

“Kelyniam continues to deliver cutting-edge technology to neurosurgeons,” said chairman and CEO Ross Bjella. “This unique implant is an important part of our regenerative product line, which includes our CustomizedBone (hydroxyapatite) implant from Finceramica, SpA, and the Osteopore range of products.”

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