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# FDA Proposes PMAs for Spinal Spheres
- URL: https://www.fdaweb.com/fda-proposes-pmas-for-spinal-spheres/
- Published: 2021-12-15T12:00:00.000Z
- Updated: 2026-09-14T17:25:56.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150777

*Federal Register* notice: FDA is proposing to require PMAs for spinal spheres, a preamendment device, for use in intervertebral fusion procedures. The proposed PMA requirement is based on the device’s risks to health, such as the need for reoperation resulting from a failed spinal sphere device or component or nerve root decompression or adjacent level disease. The agency also raised concerns about some device-related complications that may cause pain and loss of function (e.g., device fracture, deformation, loosening or extrusion). Additionally, FDA cited infection concerns involving the soft tissue, bony tissue, and the disc space , which may arise due to device implantation. To view the notice, click here.