[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.3070]

[Page 477]
 
                        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) 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 allow 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.
    (b) Classification. (1) Class II (special controls), when 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: severe spondylolisthesis (grades 3 
and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with 
objective evidence of neurologic impairment; fracture; dislocation; 
scoliosis; kyphosis; spinal tumor; and failed previous fusion 
(pseudarthrosis). These 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 that 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 
severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, 
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.''

    (2) Class III (premarket approval), when intended to provide 
immobilization and stabilization of spinal segments in the thoracic, 
lumbar, and sacral spine as an adjunct to fusion in the treatment of 
degenerative disc disease and spondylolisthesis other than either severe 
spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative 
spondylolisthesis with objective evidence of neurologic impairment.
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval for the devices described in paragraph (b)(2) of this section. 
See Sec. 888.3.

[66 FR 28053, May 22, 2001]