Kelyniam Global, Inc. Achieves FDA Clearance for New Implant
Kelyniam Global, Inc. Advances Implant Technology with FDA Clearance
Kelyniam Global, Inc. has made a significant advancement in cranial and craniofacial implant technology by securing 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Fusion™ Cranial and Craniofacial Implants. This innovative blend of Biphasic Calcium Phosphate (BCP) reinforced with Polyether Ether Ketone (PEEK) reflects a major leap in the realm of medical devices.
A Milestone in Cranial Implant Development
The landmark 510(k) clearance signifies the FDA's first approval of this particular material for cranial and craniofacial applications, which is a historic achievement in the field. Furthermore, the Fusion™ BCP-PEEK implant is the first newly introduced implant in this market segment in eight years, highlighting Kelyniam's pioneering efforts.
Company Leadership on the Innovation
Desiree Webb, Chief Operating and Revenue Officer at Kelyniam, expressed pride in being the first organization in the United States to receive FDA clearance for Fusion™ BCP-PEEK implants. She emphasized that these implants are specifically engineered to foster bone integration while offering remarkable durability and a tailored fit, which strengthens Kelyniam's position in regenerative implant solutions.
Meeting Critical Neurosurgical Needs
The Fusion™ BCP-PEEK material is specially designed to meet the nuanced demands of neurosurgery, especially in cases of traumatic injuries, tumor resection defects, or congenital anomalies where precise, patient-specific modifications are necessary. Kelyniam maintains a quick production timeline, capable of designing, manufacturing, and shipping these custom implants to surgeons in just 24 to 48 hours.
Commitment to Innovation in Neurosurgery
Ross Bjella, Chairman and CEO, underscored Kelyniam's ongoing dedication to providing advanced technology to neurosurgeons. The Fusion™ BCP-PEEK implant is a key component of their regenerative product range, which also includes the CustomizedBone™ implant made from hydroxyapatite developed by Finceramica, SpA, and the Osteopore series.
About Kelyniam Global, Inc.
Kelyniam Global, Inc. specializes in the rapid production of custom cranial and craniofacial implants employing biocompatible materials. By collaborating with neurosurgeons globally, the company is devoted to delivering high-quality, patient-centered solutions with exceptional turnaround times. Kelyniam is relentless in its pursuit of innovation in the field of regenerative medicine to improve neurosurgical care.
Frequently Asked Questions
What is the significance of the FDA clearance for Kelyniam?
The FDA clearance signifies Kelyniam's Fusion™ BCP-PEEK implant as the first of its kind approved for cranial and craniofacial applications, marking a key advance in implant technology.
How does the Fusion™ BCP-PEEK implant benefit patients?
This implant fosters bone integration and offers durability and a personalized fit, which is essential for effective patient-specific treatment solutions.
What is the production time for Kelyniam's custom implants?
Kelyniam can design, manufacture, and ship custom implants within 24 to 48 hours to ensure timely care for patients who require assistance.
Who is leading Kelyniam Global, Inc.?
Desiree Webb serves as the Chief Operating and Revenue Officer, and Ross Bjella is the Chairman and CEO, both instrumental in driving the company's innovative efforts.
What makes Kelyniam's implants unique?
Kelyniam's implants are designed with a unique blend of materials that enhance their performance and integration, catering to the specialized needs of neurosurgery.
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