[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.3070]

[Page 458-459]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 888--ORTHOPEDIC DEVICES--Table of Contents
 
                      Subpart D--Prosthetic Devices
 
Sec. 888.3070  Pedicle screw spinal system.

    (a) Pedicle screw spinal systems--(1) Identification. Pedicle screw 
spinal systems are multiple component devices, made from a variety of 
materials, including alloys such as 316L stainless steel, 316LVM 
stainless steel, 22Cr-13Ni-5Mn stainless steel, Ti-6Al-4V, and unalloyed 
titanium, that allows the surgeon to build an implant system to fit the 
patient's anatomical and physiological requirements. Such a spinal 
implant assembly consists of a combination of anchors (e.g., bolts, 
hooks, and/or screws); interconnection mechanisms incorporating nuts, 
screws, sleeves, or bolts; longitudinal members (e.g., plates, rods, 
and/or plate/rod combinations); and/or transverse connectors. The 
devices are intended to provide immobilization and stabilization of 
spinal segments in skeletally mature patients as an adjunct to fusion in 
the treatment of the following acute and chronic instabilities or 
deformities of the thoracic, lumbar, and sacral spine: degenerative 
spondylolisthesis with objective evidence of neurologic impairment, 
fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed 
previous fusion (pseudarthrosis).
    (2) Classification. Class II (special controls). Pedicle screw 
spinal systems must comply with the following special controls:
    (i) Compliance with material standards,
    (ii) Compliance with mechanical testing standards,
    (iii) Compliance with biocompatibility standards, and
    (iv) Labeling which contains these two statements in addition to 
other appropriate labeling information:
    ``Warning: The safety and effectiveness of pedicle screw spinal 
systems have been established only for spinal conditions with 
significant mechanical instability or deformity requiring fusion with 
instrumentation. These conditions are significant mechanical instability 
or deformity of the thoracic, lumbar, and sacral spine secondary to

[[Page 459]]

degenerative spondylolisthesis with objective evidence of neurologic 
impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, 
and failed previous fusion (pseudarthrosis). The safety and 
effectiveness of these devices for any other conditions are unknown.''
    ``Precaution: The implantation of pedicle screw spinal systems 
should be performed only by experienced spinal surgeons with specific 
training in the use of this pedicle screw spinal system because this is 
a technically demanding procedure presenting a risk of serious injury to 
the patient.''
    (b) Pedicle screw spinal systems for all other uses--(1) 
Identification. Pedicle screw spinal systems for all other uses are 
multiple component devices, made from a variety of materials, including 
alloys such as 316L stainless steel, 316LVM stainless steel, 22Cr-13Ni-
5Mn stainless steel, Ti-6Al-4V, and unalloyed titanium, that allow the 
surgeon to build an implant system to fit the patient's anatomical and 
physiological requirements. Such an spinal implant assembly consists of 
a combination of anchors (e.g., bolts, hooks, and/or screws); 
interconnection mechanisms incorporating nuts, screws, sleeves, or 
bolts; longitudinal members (e.g., plates, rods, and/or plate/rod 
combinations); and/or transverse connectors.
    (2) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. An 
approved PMA or a declared completed PDP must be in effect before 
placing the device in commercial distribution. See Sec. 888.3.

[63 FR 40040, July 27, 1998]