## Abstract We are developing a new spinal implant system (SIS) without fusion (bone graft). This SIS is made from two materials, metal and polyetheretherketone (PEEK) polymer. The Food and Drug Administration recommended testing __in vivo,__ in an animal model, whether the PEEK polymer could be us
Biocompatibility testing of polymers:In vivo implantation studies
β Scribed by Gourlay, Stuart J. ;Rice, Robert M. ;Hegyeli, Andrew F. ;Wade, Clarence W. R. ;Dillon, James G. ;Jaffe, Howard ;Kulkarni, R. K.
- Publisher
- John Wiley and Sons
- Year
- 1978
- Tongue
- English
- Weight
- 612 KB
- Volume
- 12
- Category
- Article
- ISSN
- 0021-9304
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β¦ Synopsis
Abstract
An in vivo method is described for screening polymeric materials for biocompatibility. The test is based on grading acute and subacute tissue reactions at 7 and 28 days, respectively, following implantation in rats. The method is reproducible and reliable. It is designed to provide uniform test criteria for biocompatibility assessment in the early phases of the development of surgical implant materials.
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