The BCP additive allows bone cells to adhere to implants more quickly, thus positively influencing the boundary, so called osteointegration, between the bone and the implant. The osteoconductivity was achieved by using a functional special additive – biphasic calcium phosphate (BCP). The high-performance polymer impresses with excellent biocompatibility and biostability as well as improved osteoconductive properties. The new PEEK filament is a biomaterial from Evonik’s VESTAKEEP® Fusion product line launched in 2020. Due to its well documented success for use in the cervical spine, PEEK-OPTIMA Natural is. Highly dense and well-adhered HA coating was developed on medical-grade PEEK using aerosol deposition (AD) without thermal degradation of the PEEK. It is well-known for its osteoconductive properties and enhancing bone apposition with a variety of implants. The objective of this work is to make an implant consisting of biocompatible PEEK with an osteoconductive HA surface for spinal or orthopedic applications.
The device is designed as an osteoconductive space- filling device to be gently packed into defect sites and used as a non-structural scaffold for the bodys natural healing and bone regeneration. Hydroxyapatite (HA) is a naturally occurring mineral and the main inorganic component of bone. BG Putty provides an osteoconductive, resorbable, biocompatible bone graft substitute made from 45S5 bioactive glass mixed with a polymer carrier. Evonik will present the new product for the first time at the AAOS trade show in Chicago, USA (March 22-26, 2022). About the Peek-Optima HA Enhanced Polymer. The high-performance polymer can be processed in common extrusion-based 3D printing technologies such as fused filament fabrication (FFF). by early 2018 as it is in its final stages of the FDA 510(k) approval process.Evonik is further expanding its portfolio of 3D-printable biomaterials for medical technology: The specialty chemicals company has developed VESTAKEEP® iC4800 3DF, a new osteoconductive PEEK filament that improves fusion between bone and implants. The ZFUZE composite technology is expected to be commercially available in the U.S. Food & Drug Administration 10903 New Hampshire Avenue Doc ID 04017.04.16 Silver Spring, MD 20993 JBenvenue Medical, Inc. “Our uniquely collaborative approach to customer projects differentiates us from other PEEK suppliers in this industry, and it allowed us to pool our respective capabilities and resources with DiFusion to solve this demanding challenge.”
“In addition to our materials expertise, Solvay’s open innovation business model was instrumental to the successful innovation of DiFusion’s ZFUZE osteoconductive composite,” Jeff Hrivnak, global business manager for healthcare at Solvay’s Specialty Polymers Business Unit, said. Polyetheretherketone (PEEK) is a high-performance, semi-crystalline engineering thermoplastic material that is an excellent choice for demanding applications.It withstands high temperatures and is resistant to chemicals and radiation. Established in 2013, Nvision is a large-scale medical device manufacturer based in San Antonio, US, with 23 FDA approved devices across different orthopaedic specialities. Osteoblast cells are attracted to the negatively charged surface at a far higher rate than titanium, and yet we were able to preserve the polymer’s outstanding visualization, modulus and strength benefits.”ĭiFusion chose to use Zeniva ZA-500 PEEK because of its higher flow that allows the compounding process to happen and the extrusion of osteoconductive implants. Its PEEK-OPTIMA HA Enhanced material has a modulus similar to bone and allows artifact-free imaging and provides an osteoconductive surface for bone on-growth, said Nvision. The Trigon system utilises Structural Encoding to enable the Unique Device Identification (UDI) required by the FDA. But we discovered if we took the silver cations out of the zeolite, they imbued PEEK with a negative charge. The Trigon Stand-Alone Osteotomy Wedge Fixation System has osteoconductive properties that promote multi-directional bone healing and improved fixation without introducing material-related bio-incompatibility reactions. “We started out engineering anti-microbial polymers by first loading zeolite particles with silver before compounding them. “It was sort of a penicillin moment,” Derrick Johns, CEO of DiFusion Technologies, said. Naturally, PEEK doesn’t promote bone growth, so DiFusion compounded negatively charged zeolites into Solvay’s Zeniva PEEK polymer. It is also inert which allows it to not cause any bad reactions with human tissue. PEEK is used as an alternative to titanium in spinal implants because it has a similar structure of bones and it can be easily seen on X-rays because of its radio transparency.
DiFusion Technologies has chosen to use Solvay’s Zeniva ZA-500 polyetheretherketone (PEEK) as the base polymer for its ZFUZE osteoconductive PEEK composite used in spinal implants.