FDA classifies screw sleeve bone fixation devices for class II assignment
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The FDA has announced a final order to classify the screw sleeve bone fixation device into class II with special controls, which will allow for increased patient access to these innovative devices, according to a press release.
Screw sleeve bone fixation devices are designed to restore stability of the implant construct by embedding with a non-resorbable metallic bone screw when the screw has lost hold due to loosening, backout or breakage, according to the release.
The new classification, which is effective on March 1, 2022, and applicable on May 1, 2020, now places screw sleeve bone fixation devices into class II assignment, rather than automatic assignment to class III by the FDA.
The FDA identified several risks, mitigation measures and special controls for screw sleeve bone fixation devices. The identified risks included the following:
- loss of function or mechanical integrity resulting from malpositioning, breakage, screw damage during insertion, deterioration due to aging or restoration of screw fixation;
- revision;
- adverse tissue reaction;
- infection; and
- febrile response due to endotoxins.
The full list of special controls and supplementary information are available in the document.
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