Biomedical Devices
OsteoFabTM Medical Devices and Implants
Breaking the mold for the medical device market.
Utilizing the most advanced materials and technology, our OsteoFabTM process can reproduce exactly what you design, or exactly what nature intended by "printing" medical implants derived directly from a CT Scan or MRI file for a perfect anatomical fit with our own OXPEKK®-IG polymers.
However, this technology allows us to go beyond merely replicating shapes: we also have the ability to meet specific performance requirements as anatomically applicable. Through our proprietary "Coherent Implantology Process", fit, form and bio-function are digitally calculated, constructed, and then produced.
Quality
Our OXPEKK®-IG materials are designed to meet the United States FDA and the European Union normative requirements for use in Long Term Human Implantable Medical Devices. OXPEKK®-IG has been tested according to ISO 10993. The biocompatibility test data and exhaustive analytical extraction studies are included in our restricted FDA Master File. With its ultimate purity and inherent mechanical and structural properties, OXPEKK®-IG has rapidly become an enabling biomaterial for the fast-growing orthopedic and reconstructive surgery industries.
In 2013, OPM received its first 510(k) for the OsteoFabTM Patient Specific Cranial Device, a 3-D printed device made from OXPEKK®-IG.
OPM's South Windsor facility is certified to ISO 9001 and ISO 13485 quality systems and 100% dimensional inspection certification.
ISO 9001 ISO 13485
Product Indications and Features
- Cranial Maxillo-Facial (Craniotomy, Orbital Reconstruction, Mandibular Reconstruction)
- Upper Extremity (non-load bearing)
- Small Bone (Hands and Feet)
- Per customer's design
Unique product benefits:
- Quick turnaround: improved fit and reduced delay for surgery
- Material density similar to cortical bone: better integration with existing bone structures
- Patient-specific shapes: reduced operating time, faster recovery, with a satisfying aesthetic result
- Suitable sterilization methods may include: Steam, Gamma, and Ethylene Oxide
Mechanical Properties
| PROPERTIES | English Unit | Metric Unit | ||
|---|---|---|---|---|
| Specific Gravity | 81.8 | lb/cb-ft | 1.31 | g/cm3 |
| MECHANICAL | ||||
| Tensile Strength (Break) | 12 | Kpsi | 83 | MPa |
| Tensile Modulus | 571 | Kpsi | 3940 | Mpa |
| Elongation (Break) | 2.5 | % | 2.5 | % |
| Flexural Strength | 26 | Kpsi | 180 | MPa |
| Flexural Modulus | 528 | Kpsi | 3640 | MPa |
| Compressive Strength | 23 | Kpsi | 160 | MPa |
All numbers represent typical in-plane values
Osteoconductivity
While manufacturing technologies are ever improving the shape and mechanical performance of orthopedic implants, few solutions have been found for stimulating bone growth and osteointegration without sacrificing device performance.
OsteoFabTM provides the answer.
Excerpts from Cell proliferation and vitality determination of osteoblasts on different materials and surface characteristics; Interpretation of laboratory data, by Timothy Ganey, Ph.D. (Download full PDF)
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PEKK appears to provide sufficient surface adhesion to support cell activity; maintaining capacity for cell proliferation without exhausting metabolic demands on the cells.
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PEKK offers an efficiency that might be described as metabolically ergonomic; activity proportional to cell need rather than proliferative exaggeration met with high activity per cell requirements as seen in both the smooth and roughened PEEK materials.
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Compared to Titanium, greater activity per cell was achieved with the PEKK material at 10 days with fewer cells.
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Expectations with implantation would be for bone attachment, sustained capacity for cell proliferation, sufficient attachment, minimal fibrosis, adequate mineral deposition, and efficient use of cell metabolism.