[Federal Register Volume 60, Number 245 (Thursday, December 21, 1995)]
[Proposed Rules]
[Page 66227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31047]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

21 CFR Part 888

[Docket No. 95N-0176]


Orthopedic Devices: Classification, Reclassification, and 
Codification of Pedicle Screw Spinal Systems; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting certain 
statements in the preamble to a proposed rule that appeared in the 
Federal Register of October 4, 1995 (60 FR 51946). The document 
proposed to classify certain unclassified preamendments pedicle screw 
spinal systems into class II (special controls), and to reclassify 
certain postamendments pedicle screw spinal systems from class III 
(premarket approval) to class II. The document states further that FDA 
is issuing for public comment the recommendations of the Orthopedic and 
Rehabilitation Devices Panel (the Panel) concerning the classification/
reclassification of pedicle screw spinal systems, and the agency's 
tentative findings on the Panel's recommendations. The document is 
being corrected to reflect an accurate description of the formation, 
membership, and activities of the Spinal Implant Manufacturers Group 
(SIMG), and the Scientific Committee, two separate entities established 
by the spinal implant manufacturers and medical professional societies 
to collect and submit to FDA all available valid scientific data on the 
performance of pedicle screw spinal devices.

FOR FURTHER INFORMATION CONTACT: Mark N. Melkerson, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2036.

     In the FR Doc. 95-24686, appearing on page 51946 in the Federal 
Register of Wednesday, October 4, 1995, the following corrections are 
made:
    1.On page 51947, in the second column, in the fourth paragraph, 
beginning in line 7, the second, third, and fourth sentences are 
removed and the following text is added in their place to read as 
follows:
    In response, two groups were founded: The Spinal Implant 
Manufacturers Group (SIMG), and the Scientific Committee. SIMG, founded 
by 16 medical device manufacturers, agreed to provide the funding that 
would be required to conduct a nationwide study of pedicle screw 
devices. The Scientific Committee was formed by five professional 
medical societies, including the North American Spine Society, the 
American Academy of Orthopedic Surgeons, the Scoliosis Research 
Society, the Congress of Neurosurgeons, and the American Association of 
Neurological Surgeons. The Scientific Committee was formed to develop 
and implement a uniform research protocol to gather clinical experience 
from the use of the device. The Scientific Committee consisted of four 
surgeons and two nonvoting SIMG representatives, a biostatistician, and 
a clinical/regulatory affairs professional.
    2. On page 51947, in the third column, in the first paragraph, 
beginning in the fifteenth line, the fourth and fifth sentences are 
removed and the following text is added in their place to read as 
follows:
    At this meeting, the Scientific Committee presented clinical data 
from its nationwide ``Historical Cohort Study of Pedicle Screw Fixation 
in Thoracic, Lumbar, and Sacral Spinal Fusions'' (Cohort Study). FDA 
presented a comprehensive review of the medical literature, an analysis 
of the medical literature, an analysis of the Cohort study conducted by 
the Scientific Committee, and a summary of the clinical data that had 
been released by IDE sponsors.
    3. On page 51950, in the first column, in the fourth paragraph, in 
the first line, the abbreviation ``SIMG'' is corrected to read 
``Scientific Committee''.

    Dated: December 8, 1995.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 95-31047 Filed 12-20-95; 8:45 am]
BILLING CODE 4160-01-F