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FDA finalizes classification of surgical instrumentation for osteochondral implants
The FDA announced orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation will be classified into class II (special controls), effective Oct. 25, 2019.
Defined by the FDA as hand-held devices intended to manipulate bone and cartilage tissue or the implant for the positioning, alignment, defect creation and placement of press-fit osteochondral implants that utilize no additional means of fixation, orthopedic surgical instruments designed for osteochondral implants with press-fit fixation include instruments specific to the geometry of the implant.
A device is classified by the FDA into class II if there is sufficient information to establish special controls that provide reasonable assurance of the safety and effectiveness of the device for its intended use in combination with general controls, which are insufficient to provide reasonable assurance of safety and effectiveness by themselves. The special controls for this device include:
- technical specifications regarding geometry of the instruments must be specified and validated to demonstrate that the instruments can safely position and place the implant;
- the patient-contacting components of the device must be demonstrated to be biocompatible; and
- labeling must include identification of implants and instruments which have been validated for use together and validated methods and instructions for reprocessing any reusable parts.
According to the FDA’s Federal Register, classifying osteochondral implants with press-fit fixation devices as class II (special controls) “will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.”
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