The Orthopedic and Rehabilitation panel for the U.S. Food and Drug Administration recommended changes to the pedicle screw's classification when it's used for treating degenerative disc disease and spondylolisthesis, according to a Medscape report. The panel recommended the traditional rigid pedicle screw spinal systems be down-classified to Class II with special controls, according to the report. The risk for allergy should be added. Dynamic stabilization systems should remain Class III.
Class II devices usually require FDA 510(k) clearance, and Class III devices, which are higher risk, require premarket approval applications.
The rigid screw system could be eligible for Class III labeling since it is a permanent implant. However, the agency determined that enough evidence supports the implant's safety. Special controls should adequately mitigate health risks, the FDA said in the report.
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Class II devices usually require FDA 510(k) clearance, and Class III devices, which are higher risk, require premarket approval applications.
The rigid screw system could be eligible for Class III labeling since it is a permanent implant. However, the agency determined that enough evidence supports the implant's safety. Special controls should adequately mitigate health risks, the FDA said in the report.
More Articles on Devices:
Spinal Elements Receives Patents on Portfolio of Lateral Lumbar Spine Approaches
Renaissance Spine System Sales Boost Mazor Q1 Profits Nearly 110%
7 Recent Orthopedic Device Company Expansions & Agreements