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 July 2005 Standards in Education

Figure 4—FDA Draft Guidance for the Preparation of Premarket Notifications (510 (k)s) for Cemented, Semi-Constrained Total Knee Prostheses
H. Materials
Provide the voluntary standards to which the materials used in each component of the device conform. Most of the materials used in legally marketed or predicate knee prostheses conform to an American Society for Testing and Materials (ASTM) or International Organization for Standardization (ISO) standard for implant usage. If not, then data must be provided demonstrating the material's biocompitability. In addition, information about the processes and effects of any additional manufacturing techniques, such as Hot Isostatic Pressing (HIP) or heat treating, must be provided.
I. Range of Motion and Constraint Data on the expected range of motion for the device should include all modes of rotation... ASTM Standard F 1223 provides a standard test method for evaluating constraint... it may be used for comparison purposes to commercially available total knee prostheses. Alternatively, constraint may be measured using a worst case analysis of the anterior, posterior, medial, lateral and rotational tibiofemoral shearing forces.

Figure 4

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