[Federal Register Volume 66, Number 99 (Tuesday, May 22, 2001)]
[Rules and Regulations]
[Pages 28051-28053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12769]



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Federal Register / Vol. 66, No. 99 / Tuesday, May 22, 2001 / Rules 
and Regulations

[[Page 28051]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. 95N-0176]


Orthopedic Devices: Classification and Reclassification of 
Pedicle Screw Spinal Systems; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
rule that classified certain previously unclassified preamendments 
pedicle screw spinal systems and reclassified certain postamendments 
pedicle screw spinal systems. The agency is correcting the rule to 
include an intended use that was inadvertently omitted from the 
codified language in the rule. In addition, the agency is correcting 
the rule to clarify that, when intended for certain uses, the device is 
a preamendments, not a postamendments, device. These actions are being 
taken under the Federal Food, Drug, and Cosmetic Act (the act), as 
amended by the Medical Device Amendments of 1976 (the 1976 amendments), 
the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug 
Administration Modernization Act of 1997 (FDAMA).

DATES: This rule is effective June 21, 2001.

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

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 27, 1998 (63 FR 40025), FDA 
published a final rule classifying certain previously unclassified 
preamendments pedicle screw spinal systems and reclassifying certain 
postamendments pedicle screw spinal systems. Following publication of 
the rule, the agency discovered that the rule contained several errors.

II. Corrections to the Rule

A. Severe Spondylolisthesis (Grades 3 and 4) at L5-S1 in Skeletally 
Mature Patients

    FDA inadvertently omitted one intended use from the codified 
language in the rule. This use, for which the device was being 
classified into class II, is treatment of severe spondylolisthesis 
(grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients 
receiving fusion by autogenous bone graft having the implants attached 
to the lumbar and sacral spine with removal of the implants after 
attainment of a solid fusion. This omission from the codification was a 
typographical error. As described in the preamble to the rule, the 
Orthopedics and Rehabilitation Devices Advisory Panel (the Panel) 
recommended classifying the device into class II when intended for this 
use, and the agency had determined that class II was the appropriate 
class. In fact, the summary of the final rule included this intended 
use in the list of intended uses for which the device was being 
classified into class II. The agency is correcting the rule, therefore, 
to include treatment of severe spondylolisthesis (grades 3 and 4) of 
the L5-S1 vertebra in skeletally mature patients receiving fusion by 
autogenous bone graft having the implants attached to the lumbar and 
sacral spine with removal of the implants after attainment of solid 
fusion in the list of class II intended uses for the device.

B. In Skeletally Mature Patients: Degenerative Spondylolisthesis With 
Objective Evidence of Neurologic Impairment; Fracture; Dislocation; 
Failed Previous Fusion (Pseudarthrosis); 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

    In the final rule, FDA described the intended uses listed above as 
postamendments intended uses. However, on March 20, 1998, prior to 
publication of the final rule, FDA cleared a premarket notification 
submission (510(k)) that included preamendments documentation showing 
that spondylolisthesis (all types and grades), spondylolysis, trauma, 
failed previous fusions (pseudarthrosis), degenerative disc disease, 
and degeneration of the facets accompanied by instability in the 
cervical, thoracic, lumbar and sacral spine (C2-S1) are preamendments 
intended uses (Ref. 1). The 510(k) submission included affidavits 
establishing preamendments use from the original device marketer, the 
device inventor, credible users, and the sponsor of the 510(k). CDRH's 
Office of Compliance found these documents adequate to establish the 
preamendments status of this device as a pedicle screw spinal system 
for specific indications. Consequently, the rule should have stated 
that for these intended uses, the device was being classified, not 
reclassified.
    FDA acknowledges that the additional preamendments intended uses 
should have been incorporated into the final rule prior to its 
publication. If this had been done, the codified language would be as 
it is below. The agency regrets any inconveniences that this delay in 
incorporating the additional preamendments intended uses may have 
caused.
1. In Skeletally Mature Patients: Degenerative Spondylolisthesis With 
Objective Evidence of Neurologic Impairment; Fracture; Dislocation; and 
Failed Previous Fusion (Pseudarthrosis)
    FDA's error in referring to the device when intended to treat 
degenerative spondylolisthesis with objective evidence of neurologic 
impairment, fracture, dislocation, or failed previous

[[Page 28052]]

fusion (pseudarthrosis), as a postamendments, rather than a 
preamendments, device did not affect the classification into class II 
under the final rule. The agency intended to classify the device when 
intended for these uses into class II. In addition, the requirement 
that the agency obtain a recommendation from an advisory panel 
regarding the classification of a preamendments device was met because 
the Panel considered these intended uses when making its recommendation 
(Ref. 2). The fact that these are preamendments devices, rather than 
postamendments devices, intended uses has no impact on either the 
classification of the device or the premarket submissions required for 
pedicle screw spinal systems intended for these uses. In addition, no 
change in the codified language of the rule is necessary to reflect 
this fact.
2. 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
    FDA also described the device when intended to treat degenerative 
disc disease and spondylolisthesis other than severe spondylolisthesis 
(grades 3 and 4) at L5-S1 as a postamendments, rather than as a 
preamendments, device. This error did not affect the classification of 
the device, when intended for these uses, into class III under the 
final rule. The agency intended to classify the device when intended 
for these uses into class III. In addition, the requirement that the 
agency obtain from an advisory panel a recommendation regarding the 
classification of a preamendments device was satisfied because the 
Panel considered these intended uses when making its recommendation 
(Ref. 2).
    However, the agency's error does affect the type of premarket 
submission required for the device when intended for these uses. 
Because these are preamendments intended uses, premarket approval 
applications are not required until the agency issues a final rule 
under section 515(b) of the act (21 U.S.C. 360e(b)) requiring 
submission of premarket approval applications. FDA intends to initiate 
the call for premarket approval applications for the device when 
intended for these uses in a future document in the Federal Register. 
Until that time, the devices may enter the market after clearance of a 
premarket notification (510(k)) submission. The agency is correcting 
the rule accordingly.

C. Spondylolysis and Degeneration of the Facets Accompanied by 
Instability in the Thoracic, Lumbar and Sacral Spine; Severe 
Spondylolisthesis (Grades 3 and 4) at L5-S1 in the Nonskeletally Mature 
Population; Treatment of Cervical Spondylolisthesis (All Grades and 
Types); Cervical Spondylolysis; Cervical Degenerative Disc Disease; 
Degeneration of the Cervical Facets Accompanied by Instability; 
Cervical Trauma (Fracture and Dislocation); and Revision of Failed 
Previous Fusion Surgery (Pseudarthrosis) of the Cervical Spine

    On January 20, 1995, the agency cleared a 510(k) that included 
documentation that use of pedicle screw spinal systems to treat severe 
spondylolisthesis (grades 3 and 4) at L5-S1 in patients receiving 
fusion by autogenous bone graft having the implants attached to the 
lumbar and sacral spine with removal of the implants after attainment 
of a solid fusion is a preamendments intended use. While the 
preamendments indication originally described by the agency in the 
final rule was limited to skeletally mature patients, the preamendments 
documentation also supports the use of this pedicle screw spinal system 
for the same intended use in patients who are not skeletally mature 
(Ref. 3).
    In addition, the March 20, 1998, 510(k) clearance described above 
in section II.B of this document identified a number of intended uses 
that were not included as part of the final rule, specifically:
    (1) Spondylolysis in the thoracic, lumbar and sacral spine;
    (2) Degeneration of the facets accompanied by instability in the 
thoracic, lumbar and sacral spine;
    (3) Cervical spondylolisthesis (all grades and types);
    (4) Cervical spondylolysis;
    (5) Cervical degenerative disc disease;
    (6) Degeneration of the cervical facets accompanied by instability;
    (7) Cervical trauma (fracture and dislocation); and
    (8) Revision of failed previous fusion surgery (pseudarthrosis) of 
the cervical spine.
    Neither the use in nonskeletally mature patients nor the eight 
intended uses listed above were discussed by the Panel at either its 
August 20, 1993, or July 23, 1994, meetings or as part of the 
information they subsequently reviewed. Because they are preamendments 
intended uses, a panel recommendation is required before they may be 
classified (21 U.S.C. 360c(c)). FDA intends to seek the recommendation 
of an advisory panel with respect to classification of the device when 
intended for these uses at a future Panel meeting. For these intended 
uses, the device currently is considered an unclassified preamendments 
device and may enter the market after clearance of a 510(k) submission.

D. Summary of the Revisions to Sec. 888.3070

    In light of the above, FDA has made the following changes to 
Sec. 888.3070:
    (1) FDA has reorganized the section to simplify the presentation.
    (2) FDA has added ``severe spondylolisthesis (grades 3 and 4) of 
the L5-S1 vertebra'' to the intended uses for the class II pedicle 
screw spinal systems (Sec. 888.3070(b)(1)). FDA has also added this 
intended use to the labeling for the special controls.
    (3) FDA has changed the intended uses for which pedicle screw 
spinal systems are in class III from ``all other uses'' to ``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'' (Sec. 888.3070(b)(2)).
    (4) FDA has amended Sec. 888.3070(c) to state that, for the devices 
described in paragraph Sec. 888.3070(b)(2), no effective date has been 
established for submission of a premarket approval application (PMA) or 
a notice of completion of a product development protocol (PDP). FDA 
will issue a rule to require PMA's or PDP's for these devices in the 
future. Until that time, pedicle screws for these intended uses may be 
marketed through the premarket notification process.
    (5) At a future time, and after obtaining a Panel recommendation, 
FDA will propose a rule to classify the device for the unclassified 
uses described in section II.C of this document

III. References

    The following references have been placed on display in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. These references may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.

    1. K970599, Sofamor Danek Townley Pedicle Screw Plating System.
    2. Food and Drug Administration Orthopedic and Rehabilitation 
Devices

[[Page 28053]]

Advisory Panel Meeting transcripts, Gaithersburg, MD, July 22, 1994.
    3. K932029, Sofamor Danek TSRH Spinal System.

IV. Environmental Impact

    The agency had determined under 21 CFR 25.30(i) that this final 
rule is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

V. Analysis of Impacts

    FDA has examined the impact of the final rule under Executive Order 
12866 and the Regulatory Flexibility Act (5 U.S.C 601-612) (as amended 
by subtitle D of the Small Business Regulatory Fairness Act of 1996 
(Public Law 104-121)), and the Unfunded Mandates Reform Act of 1995 
(Public Law 104-4). Executive Order 12866 directs agencies to assess 
all costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The agency believes that this rule is consistent with the 
regulatory philosophy and principles identified in the Executive order. 
In addition, this rule is not a significant regulatory action as 
defined by the Executive order and so is not subject to review under 
the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. The only effect of this correction is to delay the 
requirement for manufacturers of pedicle screw spinal systems intended 
for certain uses to submit PMA's for these devices until FDA issues a 
regulation requiring such submissions. Therefore, the agency certifies 
that this final rule will not have a significant economic impact on a 
substantial number of small entities. This rule also does not trigger 
the requirement for a written statement under section 202(a) of the 
Unfunded Mandates Reform Act because it does not impose a mandate that 
results in an expenditure of $100 million or more by State, local, or 
tribal governments in the aggregate, or by the private sector, in any 
one year.

List of Subjects in 21 CFR Part 888

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
888 is amended as follows:

PART 888--ORTHOPEDIC DEVICES

    1. The authority citation for 21 CFR part 888 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    2. Section 888.3070 is revised to read as follows:


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.

    Dated: May 11, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-12769 Filed 5-21-01; 8:45 am]
BILLING CODE 4160-01-S