Medical ceramics for bone graft substitute in orthopedic, dental and sports medicine applications
DSM specializes in the design, development, commercialization and manufacturing of bioceramic medical devices. Bioceramics have a long history of being used as a bone graft substitute in orthopedic, dental and sports medicine applications. When properly designed, bioceramics provide an ideal synthetic osteoconductive scaffold for bone regeneration.
Bioceramic Development Lab DSMs fully equipped state of the art ceramic development lab and testing facility can facilitate your development efforts. DSMs knowledge and technical capabilities allow for bioceramics to be designed and developed to best meet our partners medical device needs and can be supplied in a number of forms to provide optimal handling characteristics for the end application.
Design and manufacturing of ceramic medical devices Our diverse design and manufacturing capabilities allow for bioceramic medical devices to be provided as powders, granules, porous shapes, settable pastes, settable putties and anorganic bone. By collaborating with our knowledgeable development and commercialization teams, we can guide and assist in the co-development or customization of your bioceramic product.
Bionate® PCU is well known as an industry-leading medical grade polymer successfully used in long-term implants for many years. It has outstanding physical properties and excellent biocompatibility and biostability proven by use in a number of medical devices covering several therapeutic areas.
Bionate® II PCU is the next generation in our industry leading family of materials with built-in surface modification technology. It offers added strength, improved oxidative stability and enhanced processability.
These polymers feature a unique combination of toughness and biostability, making them ideal for chronically implanted devices. Extensive testing has demonstrated their outstanding mechanical properties, and Bionate® is backed by our FDA Master File with extensive biocompatibility test data.
Benefits Bionate® PCU
Proven clinical use
Combines flexibility with strength
In vivo biostability, biocompatibility and oxidative stability
Tough, load-bearing qualities
Outstanding abrasion resistance when compared to conventional silicone elastomers
Customizable with SME® technology, utilizing surface modifying end groups
FDA Master File
Bionate® II PCU
Wide range of potential surface characteristics using DSMs patented Self-Assembling Monolayer End Group (SAME®) technology
Product category: Product design, product development
Polymer and Composite Processing
DSM has extensive experience in the design, development, manufacture and sterilization of medical devices made from synthetic resorbable and permanent (non-resorbable) polymers. These devices serve the sports medicine, spine, trauma, craniomaxilofacial, and dental markets.
Resorbable (bioresorbable and bioasorbable) materials Our bioresorbable mateials include orthopedic screws, anchors, pins and plates and high-strength reinforced products such as trauma repair plating systems. We also specialize in porous scaffolds made from the same resorbable materials which are cleared for use as bone void fillers and membrane barriers. Additives such as ceramics or bioactive glass can be incorporated into these devices to enhance their behavior.
Copolymer blends of these materials
Permanent materials Commercial examples include orthopedic screws, anchors, pins and interbody spine fusion devices.
Thermoplastic Polyurethanes (TPU)
Composites Custom-blends of polymers with ceramics, fiber, fillers or dyes to achieve unique properties including:
Osteointegration and osteocondusction
Project and processing capabilities We have an experienced and diversified staff of business and technical experts to be a trusted partner for our customers. Our extensive processing capabilities include:
25,000 ft² of cleanroom manufacturing space
Injection molding (vertical and horizontal)
Single and twin screw extrusion
Laser cutting and perforation of films
In-house mold making
Biomedical testing services
Chemical, mechanical and analytic test capabilities
In vitro degradation and accelerated aging studies
Shelf life and packaging stability studies
Contract testing for design optimization, regulatory submissions, and lot release
DSM is registered with the US FDA as a medical device manufacturer. Our quality management system is certified to ISO 13485 and the Exton, PA facility is UKAS accredited.
DSM is the leading medical device materials development and manufacturing partner in the world. We help medical device companies develop products that address many growing trends in medicine – from treating an aging population to caring for a more active one– meeting the need for safer, less invasive procedures that are also more cost-effective.
Innovative biomedical materials and technology expertise With more than 30 years of experience, medical device manufacturers and pharmaceutical companies have obtained the most advanced and trusted materials and technology from DSM, benefiting 10.5M+ patients annually. Our team of 400+ biomedical specialists is constantly turning ideas into innovative materials and devices of the highest quality that address the unmet healthcare needs of today and tomorrow.