United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2016_register executive 2016-12-30 article Rules and Regulations D09002ee1c7f3047f D09002ee1c7f304ee United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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. 81 FR 96366 https://www.govinfo.gov/app/details/FR-2016-12-30/2016-31670 2016-31670 fr30de16-10 4164-01-P Docket No. FDA-2014-N-1205 https://www.govinfo.gov/app/details/FR-2016-12-30/2016-31670 https://www.govinfo.gov/content/pkg/FR-2016-12-30/html/2016-31670.htm https://www.govinfo.gov/content/pkg/FR-2016-12-30/pdf/2016-31670.pdf Medical Devices 9 p. 96366 96374 81 FR 96366 Title 21 Part 888 21 CFR Part 888 Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems; Federal Register Vol. 81, Issue RULE 2016-31670 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2016-12-30 Docket No. FDA-2014-N-1205 4164-01-P 2016-31670 Final order.

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.

This order is effective on December 30, 2016. See further discussion in section V, "Implementation Strategy." Constance P. Soves, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1437, Silver Spring, MD 20993, 301-796- 6951, Constance.Soves@fda.hhs.gov. Medical Devices Medical Devices: Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth to be known as Thoracolumbosacral Pedicle Screw Systems, including Semi-Rigid Systems , Constance.Soves@fda.hhs.gov http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm352525.htm https://www.astm.org/Standards/F1717.htm https://www.hindawi.com/journals/aorth/2013/745610/ https://www.regulations.gov Vol. 81, no. 251 Office of the Federal Register, National Archives and Records Administration 2016-12-30 continuing daily deposited born digital 791 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-12-30 P0b002ee19330568a 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr30de16 https://www.govinfo.gov/app/details/FR-2016-12-30 https://www.govinfo.gov/content/pkg/FR-2016-12-30/pdf/FR-2016-12-30.pdf https://www.govinfo.gov/content/pkg/FR-2016-12-30/xml/FR-2016-12-30.xml fdlp 96329 97110 DGPO 2016-12-30 2024-06-01 FR-2016-12-30 machine generated eng FR FR-2016-12-30 81 251