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Kelyniam Global, Inc. Receives FDA Clearance for Innovative Fusion™ BCP-PEEK Implant
Kelyniam Global, Inc. Receives FDA Clearance for Innovative Fusion™ BCP-PEEK Implant.
About this update from Kelyniam Global, Inc.
[{"type":"text","content":"\r\n\r\n \r\n \r\n Kelyniam Global, Inc. Receives FDA Clearance for Innovative Fusion™ BCP-PEEK Implant\r\n \r\n \r\n\r\n\r\nKelyniam Global, Inc. Receives FDA Clearance for Innovative Fusion™ BCP-PEEK Implant\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\nCANTON, Conn., Sept. 18, 2025 /PRNewswire/ -- Kelyniam Global, Inc. (Kelyniam), a leading provider of custom cranial and craniofacial implant solutions, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Fusion™ Cranial and Craniofacial Implants. These implants are crafted from a unique combination of Biphasic Calcium Phosphate (BCP) reinforced with Polyether Ether Ketone (PEEK), marking a groundbreaking advancement in implant technology.\r\n\r\nThis 510(k) clearance marks the first time the FDA has approved this material for use in cranial and craniofacial implants, representing a significant milestone in implant technology. The Fusion™ BCP-PEEK implant is the first totally new implant launched in the cranial and craniofacial market in 8 years.\r\n\"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, 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.\"\r\nDesigned for custom applications , the Fusion™ BCP-PEEK material meets critical neurosurgery needs where precise, patient-specific solutions are essential for treating traumatic injuries, defects from tumor resections, or congenital anomalies. As with Kelyniam's PEEK implants, Fusion™ BCP-PEEK custom implants can be designed, manufactured and shipped to surgeons within 24-48 hours, ensuring timely care for patients in need.\r\nRoss Bjella, Chairman and CEO, added, \"Kelyniam continues to deliver cutting-edge technology to neurosurgeons. 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.\"\r\n About Kelyniam Global, Inc. Kelyniam ...