[Federal Register: May 22, 2001 (Volume 66, Number 99)]
[Rules and Regulations]
[Page 28051-28053]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22my01-1]
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Rules and Regulations
Federal Register
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[[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