What’s in a name? At MedShape, our name conveys our very essence: science driven medical devices that utilize the unique capabilities of a new generation of biomaterials. MedShape has several innovative material technology platforms that convey how our vision, expertise, and passion continue to evolve orthopedic surgery. Are you ready to evolve with us?
NEW! 3-D METAL ALLOY PRINTING
Additive manufacturing (or 3-D printing) is an emerging materials processing technology. This novel technology removes any design constraints due to the manufacturing process and provides complete flexibility to design a medical device specific to its desired function and application. In particular, 3-D printing allows for devices to be fabricated with complex geometric features (e.g. internal channels, porosity) or customized to match a patient’s specific anatomy. 3-D printing can also improve manufacturing efficiency enabling devices to be fabricated in small batches at a lower cost with quicker turnaround.
Despite 3-D printing’s numerous advantages, few 3-D printed metal orthopaedic devices have reached clinical use due to the negative impact the fabrication process imposes on the material’s mechanical properties, putting 3-D printed devices at risk of failure in many load-bearing orthopaedic applications.1 MedShape is one of the first companies to develop and FDA clear a titanium alloy bone plate utilizing a novel 3-D printing process that maintains the mechanical properties close to the original bulk material.2
SURFACE POROUS POLYMERS
Porous materials are a class of micro-structured materials associated with promoting adjacent tissue in-growth.3 The use of porous polymers, to date, has been limited in orthopaedic load-bearing applications due to the loss in mechanical properties typically associated with introducing porosity in a material.
While porous metals have found their way into clinically-used devices, MedShape is the first company to develop and receive FDA clearance for devices manufactured with a porous polyetheretherketone (PEEK) material. Unlike other porous polymer materials used clinically, our PEEK Scoria™ biomaterial uses a proprietary processing method that seamlessly connects a porous surface to a solid base without compromising the mechanical integrity of the device itself. Developed by a group of engineers and researchers at Georgia Institute of Technology, PEEK Scoria has the following key characteristics:4
- 65% porosity
- 300 micron average pore size
- 99% interconnectivity
- 2X shear strength of trabecular bone
- Comparable fatigue strength and modulus to traditional PEEK
Devices manufactured from PEEK Scoria are biocompatible, biostable, radiolucent, and MRI safe.
SHAPE MEMORY POLYMERS (SMPs)
Shape memory polymers (SMPs) are a class of "smart" materials. Shape memory polymers can "remember" multiple shapes and transition easily between those shapes when triggered to do so. SMPs can deform up to 400% and still recover their original shape without a loss of mechanical integrity. Appropriate triggers for shape change include: heat; light and mechanical force.
Though researchers have developed numerous formulations of SMPs, MedShape is the only company to have developed and introduced FDA cleared devices manufactured from shape memory polymers based on PEEK (polyetheretherketone) and PMMA (polymethylmethacrylate) chemistries. Our proprietary PEEK Altera® biomedical polymer allows devices to enter the target surgical site in a compact geometry and then be triggered to deploy, with minimal mechanical force, into the optimal geometry for fixation. Devices manufactured from PEEK Altera are biocompatible, biostable, radiolucent and MRI safe.
SHAPE MEMORY ALLOYS (SMAs)
Shape memory alloys (SMAs) have a history of successful human implantation in biomedical devices such as self-expanding cardiac stents, guide wires and orthopedic staples. Nickel-titanium (NiTi, Nitinol) is the most commonly used SMA and is capable of recovering strains up to 10 times more than traditional metals and alloys. SMAs have the ability to change their shape up to 8% and still fully recover their original geometry.
Fixation devices incorporating shape memory alloys can respond to local changes in the site of implantation, such as bone resorption, maintaining apposition of bony fragments and sustaining compression across fractures or fusion zones. We are the first company to clear through the FDA a bone fusion device comprised of both titanium and nickel-titanium, paving the way for a range of devices that are both strong and dynamic.
1Chen J, Zhang Z, Chen X, Zhang C, Zhang G, Xu Z. Design and manufacture of customized dental implants by using reverse engineering and selective laser melting technology. The Journal of prosthetic dentistry 2014.
2Data on file. MedShape, 2014.
3E. S. Place, N. D. Evans, M. M. Stevens, Nat Mater 2009, 8, 457.
4NT Evans, FB Torstrick, CSD Lee, et. al. High-strength, surface-porous polyether-ether-ketone for load-bearing orthopedic implants. Acta Biomaterialia, 2015; 13: 159-167.