# Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems
> **Food and Drug Administration** · Final order. · Published 2016-12-30 · Effective 2016-12-30 · 81 FR 96366
## Document
- **Document number:** 2016-31670
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 81 FR 96366
- **CFR reference:** 21 CFR 888
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2016/12/30/2016-31670/orthopedic-devices-reclassification-of-pedicle-screw-systems-henceforth-to-be-known-as)
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