This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

28051

Vol. 66, No. 99

Tuesday, May 22, 2001

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.

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

28052 Federal Register / Vol. 66, No. 99 / Tuesday, May 22, 2001 / Rules and Regulations

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

§ 888.3070

In light of the above, FDA has made

the following changes to § 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

(§ 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’’

(§ 888.3070(b)(2)).

(4) FDA has amended § 888.3070(c) to

state that, for the devices described in

paragraph § 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

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

§ 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-6Al4V, 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 § 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

DEPARTMENT OF COMMERCE

United States Patent and Trademark

Office

37 CFR Part 1

[Docket No.: 010202029–1112–02]

RIN 0651–AB35

Revision of Patent Cooperation Treaty

Application Procedure; Correction

AGENCY: United States Patent and

Trademark Office, Commerce.

ACTION: Final rule; correction.

SUMMARY: The United States Patent and

Trademark Office (Office) published a

final rule in the Federal Register of

March 22, 2001, revising the rules of

practice relating to applications filed

under the Patent Cooperation Treaty

(PCT) to conform the United States rules

of practice to the PCT Regulations that

became effective on March 1, 2001. This

document corrects three errors in that

final rule.

EFFECTIVE DATE: March 22, 2001.

FOR FURTHER INFORMATION CONTACT:

Charles Pearson, Director, Office of PCT

Legal Administration, by telephone at

(703) 306–4145; or by mail addressed to:

Box PCT, Commissioner for Patents,