Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems
other · Food and Drug Administration · Rule · Published 2016-12-30 · Effective 2016-12-30 · 81 FR 96366
Document
Document number
2016-31670
Federal Register citation
81 FR 96366
CFR reference
21 CFR 888
Type
Rule
Action
Final order.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2016-12-30
Effective date
2016-12-30
HHS docket
Docket No. FDA-2014-N-1205
Abstract
The Food and Drug Administration (FDA) is issuing a final order to reclassify pedicle screw systems, a preamendments class III device (regulated under product code NKB), into class II (special controls), renaming the device "thoracolumbosacral pedicle screw systems"; reclassify dynamic stabilization systems, a subtype of pedicle screw systems regulated under product code NQP when used as an adjunct to fusion, into class II (special controls), renaming this device subtype "semi-rigid systems"; and clarify the device identification of pedicle screw systems to more clearly delineate between rigid pedicle screw systems and semi-rigid systems. FDA is finalizing this action based on a reevaluation of information pertaining to the device type.