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# Bone Fixation Screw Sleeve Class 2
- URL: https://www.fdaweb.com/bone-fixation-screw-sleeve-class-2/
- Published: 2022-03-01T12:00:00.000Z
- Updated: 2026-09-14T17:34:42.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151259

*Federal Register* notice: FDA is classifying the screw sleeve bone fixation device into Class 2 (special controls). The action was taken in response to a Woven Orthopedic Technologies de novo classification request for its OGmend Implant System, which is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase (grip) due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone and provides increased surface area to create an interference fit to restore stability of the implant construct. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-03-01/pdf/2022-04154.pdf?ref=fdaweb.com).