3dpbm’s AM Focus Medical continues to zoom in on the many possibilities that additive manufacturing is offering today to medical companies. We are now taking a closer look at Zimmer Biomet additive manufacturing, which includes the global distribution (exclusive in the US) of unique PEKK 3D printed implants by Oxford Performance Materials. In the previous episodes, we looked at other giants such as Stryker, J&J and Lima Corporate as well as interesting SMEs and startups. Upcoming episodes will continue to include many different types of players in this segment, ranging from highly innovative startups and SMEs to giant multinational corporations. At the end of the month, all the best content will be featured in 3dpbm’s Medical AM Focus 2020 eBook.
When Zimmer met Biomet…
Zimmer Biomet is the result of a 2015 merger between two orthopedic industry leaders, Zimmer and Biomet. Zimmer had been steadily ramping up its use of additive manufacturing technologies in the production of various orthopedic implants, and today additive manufacturing has infiltrated a broad swath of the company’s portfolio. The company’s OsseoTi Porous Metal Technology uses human CT data in combination with SLM 3D printing technology to build a structure that directly mimics the architecture of human cancellous bone. Using a proprietary manufacturing process, constructs are printed to build a fully-integrated component with solid and porous regions. This process maintains the consistent porosity and strength necessary to facilitate tissue in-growth and implant stability.
Zimmer Biomet’s OsseoTi Porous Metal Technology is made from the highly biocompatible Ti6Al4V alloy material that has excellent corrosion resistance and a proven history of clinical success. Mimicking the porous structure of human cancellous bone, the physical properties of OsseoTi Porous Metal are designed for the potential of bone integration. This porous metal structure facilitates tissue ingrowth and remodeling, vascularization, and very close attachment between bone and the metal.
Zimmer is involved with additive manufacturing in the production of standard-sized devices in the knee, spine, and foot and ankle extremity segments. It also provides an offering for patient-specific implants focusing primarily on the shoulder and hip, although it is not immediately clear to what degree its additive manufacturing technology is playing a role in these areas. Zimmer Biomet’s Vault shoulder reconstruction system utilizes printed surgical cutting guides, and its triflange hip replacement products are said to be manufactured custom for each procedure, but whether or not additive manufacturing is being applied specifically to produce the implants themselves is not clear today, given the heavy continued usage of other technology like plasma/cold spray.
…And Biomet met OPM
In addition to its metal additively manufactured products that Zimmer produces directly, the company also markets and distributes Oxford Performance Materials’ (OPM) 3D printed PEKK craniomaxillofacial implants worldwide. The deal dates back to 2013 when Oxford Performance Materials (OPM) and Biomet Microfixation (Biomet) entered into an exclusive distribution agreement for OPM’s OsteoFab Patient-Specific Cranial Device (OPSCD). Under the terms of the agreement, Biomet gained exclusive global distribution rights to the OPSCD and OsteoFab implants for craniomaxillofacial (CMF).
OPM’s OsteoFab technology combines OXPEKK-IG polymer (PEKK or polyetherketoneketone), a biocompatible material with properties like bone, with SLS 3D printing in order to produce bespoke devices and patient-specific designs created directly from a CT or MRI scan. OXPEKK-IG polymer has been used in implant devices for several years and is supported by extensive biocompatibility and clinical data. OPM began producing CMF implants as a contract manufacturer in late 2011 and received FDA clearance for their own OPSCD in February 2013.
Scott DeFelice (who was a guest of 3dpbm’s webinar on the future of 3D printed orthopedic implants last year). founded OPM in 2000 as the first company to successfully apply additive manufacturing solutions to PEKK, creating a unique “toolbox” by applying proprietary OXPEKK composition IP with process and application technology. The Company began to incorporate 3D printing technology to its OXPEKK material in 2006. As a pioneer in personalized medicine, OPM Biomedical became the first company to receive FDA clearance to manufacture 3D printed patient‐specific polymeric implants when it received 510(k) clearance for its cranial prostheses line for surgeons around the world in February 2013. OPM now has additional FDA clearances and is an original equipment manufacturer (OEM) for maxillofacial implants as well as its first spinal implant line. OPM also provides contract manufacturing services to third parties for a broad range of 3D printed biomedical implant applications.