Class II Special Controls Guidance

Document: Hip Joint M&al/Polymer

Constrained Cemented or Uncemented
Prosthesis; Draft Guidance for
Industry and FDA

Draft Guidance - Not for Implementation

This guidance document is being distributed for comment purposes only.

Draft released for comment on [release date as stated in FR Notice]

U.S. Department of Health and Human Services

Food and Drug Administration
Center for Devices and Radiological Health

Orthopedics Devices Branch

Division of General, Restorative, and Neurological Devices
Office of Device Evaluation
 Draft - Not for Implementation

Preface
Public Comment

For 90 days following the date ,of publication in the Federal Register of the notice
announcing the availability of this guidance, comments and suggestions regarding
this document should be submitted to the Docket No. assigned to that notice,
Dockets Management Branch, Division of Management Systems and Policy,
Office of Human Resources and Management Services, Food and Drug
Administration, 5630 Fishers Lane, Room 1061, (ISA-305), Rockville, MD 20852.

Additional Copies

Additional copies are available from the Internet at:

http://www.fda.gov/cdrh/[specific address], or CDRH Facts-On-Demand. In order to
receive this document via your fax machine, call the CDRH Facts-On-Demand system
at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the
system. At the second voice prompt, press 1 to order a document. Enter the
document number 1328 followed by the pound sign (#). Follow the remaining voice
prompts to complete your request.
 Draft - Not for Implementation

Class II Special Controls Guidance

Document: Hip Joint Metal/Polymer
Constrained Cemented or Uncemented
Prosthesis; Draft Guidance for Industry and
FDA
This document is intended to provide guidance. It represents the Agencys current
thinking on this topic. It does not create or confer any rights for or on any person and
does not operate to bind the Food and Drug Administration (FDA) or the public. An
alternative approach vhay be used ifsuch approach satisfies the requirements of the
applicable statute and regulations.

Background
This guidance document was developed as a special control guidance to support the
reclassification of the hip joint metal/polymer constrained cemented or uncemented prosthesis
into class II. This guidance will be issued in conjunction with a Federal Register notice
announcing the proposal to reclassify this device type. This guidance is issued for comment
purposes only. If a final rule to reclassify this device type is not issued, this guidance document
will not be issued as a special control.

FDA believes that special controls, when combined with the general controls, will be sufficient
to provide reasonable assurance of the safety and effectiveness of the hip joint metal/polymer
constrained cemented or uncemented prosthesis. If the device is reclassified, a manufacturer who
intends to market a device of this generic type must (1) conform with the general controls of the
Food, Drug & Cosmetic Act, including the 510(k) requirements described in 21 CFR 807.8 1, (2)
address the specific risks to health associated with the hip joint metal/polymer constrained
cemented or uncemented prosthesis, and (3) receive a substantial equivalence determination from
FDA prior to marketing the device.

This special control guidance document identifies the classification, product code, and
classification definition for the generic hip joint metal/polymer constrained cemented or
uncemented prosthesis. In addition, it identifies the risks to health and serves as the special
control that, when followed and combined with the general controls, will generally address the
risks associated with this generic device type and lead to a timely 5 1O(k) review and clearance.
For the specific content requirements of a 5 1O(k) submission, preparers of submissions should
refer to 21 CFR 807.87 and other agency documents on this topic.

page 1
 D+aft - Not for Implementation

Scope
FDA identifies the generic hip joint metal/polymer constrained cemented or uncemented
prosthesis as an orthopedic device classified under 21 CFR 888.33 10, product code KWZ. A hip
joint metal/polymer constrained cemented or uncemented prosthesis is intended to replace a hip
joint. The device prevents dislocation in more than one anatomic plane and has components that
are linked together. This generic type of device includes prostheses that have a femoral
component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component
made of ultra-high-molecular-weight polyethylene with or without a metal shell made of alloys,
such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is
intended for use with or without bone cement (888.3027).

Risks to Health
FDA has identified the following four risks to health associated with the use of the hip joint
metal/polymer constrained cemented or uncemented prosthesis:

1. infection
2. adverse tissue reaction
3. pain and/or loss of function
4. revision

The.guidance documents, consensus standards, and labeling statements that follow will help
manufacturers address the identified risks to health.

Controls
FDA believes that this special control will address the above identified risks to health associated
with the use of the device. Manufacturers attempting to establish that their hip joint
metal/polymer constrained cemented or uncemented prosthesis is substantially equivalent to a
predicate hip joint metal/polymer constrained cemented or uncemented prosthesis device should
demonstrate that their device complies with either the specific recommendations of this guidance
or with an alternate means to establish equivalent safety and effectiveness .of their device.

Manufacturers who reference recognized standards as part of their 5 1O(k) submission should
provide statements regarding conformance or Declarations of Conformity under the FDA
Modernization Act of 1997. Because statements afford greater flexibility for device developers
than Declarations of Conformity, submitters of 5 1O(k)s should consider using guidance
documents and consensus standards in this manner. For information regarding declarations of
conformity, refer to FDAs Guidance on Recognition and Use of Consensus Standards, which
is available on our website at http://www.fda.gov/cdrh/modact/k982.html.

The FDA guidance documents, which present FDAs current thinking, and consensus standards
listed below will contribute to the design, manufacture, and clearance of safe and effective hip
prosthesis: They also will help manufacturers address material concerns and performance testing

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 Draft - Not for Implementation

methods for the device to reduce the identified risks associated with use of the .device. The
labeling statements listed below will provide information to practitioners that will contribute to
safe and effective use of the device.

1. FDA Guidance Documents:

a. Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces
Apposing Bone or Bone Cement
b. Guidance Document for Testing Non-articulating, Mechanically Locked Modular
Implant Components
c. Draft Guidance Document for the Preparation of Premarket Notification (5 1O(k))
Applications for Orthopedic Devices-The Basic Elements
d. Data Requirements for Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in
Orthopedic Devices
e. 5 1O(k) Sterility Review Guidance K90-1 dated 02/12/l 990
f Draft Guidance Document for Femoral Stem Prostheses
g- Draft Guidance Document for Testing Acetabular Cup Prostheses

Consensus Standards:

a. American Society for Testing and Materials (ASTM) Consensus Standards:

1) F 67-95, Standard Specifications for Unalloyed Titanium for Surgical Implant

Applications
2) F 75-98, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Casting
Alloy and Cast Products for Surgical Implants (UNS R 30075)
3) F 86-00, Practice for Surface Preparation and Marking of Metallic Surgical
Implants
4) F 90-97, Specification for Wrought Cobalt-20 Chromium-l 5 Tungsten-l 0 Nickel
Alloy for Surgical Implant Applications (UNS R3 0605)
5) F 136-98, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium
ELI (Extra Low Interstitial) Alloy (UNS R5,6401) for Surgical Implant Applications
6) F 138-97, Specification for Wrought 18 Chromium - 14 Nickel - 2.5 Molybdenum
Stainless Steel Bar and Wire for Surgical Implants (UNS S3 1673)
7) F 562-95, Specification for Wrought Cobalt-35 Nickel-20 Chromium-10
Molybdenum Alloy for Surgical Implant Applications
8) F 620-97, Specification for Titanium-6 Aluminum-4 Vanadium ELI Alloy Forgings
for Surgical Implants (UNS R56401)
9) F 648-98, Standard Specification for Ultra-High Molecular Weight Polyethylene
Powder and Fabricated Form for Surgical Implants
10) F 745-95, Specification for 18 Chromium - 12.5 Nickel 2.5 Molybdenum Stainless
Steel for Cast and Solution-Annealed Surgical Implant Applications
11) F 746-87 (99), Test Method for Pitting or Crevice Corrosion of Metallic Surgical
Implant Materials
12) F 799-96, Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for
Surgical Implants (UNSR3 11537)
13) F 983-86 (96), Practice for Permanent Marking of Orthopedic Implant Components

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 Not for Implementation

14) F 1044-95, Standard Test Method for Shear Testing(of Porous Metal Coatings
15) F 110897a, Specification for Titanium-6 Aluminum-4 Vanadium Alloy Casting for
Surgical Implants (UNS R56406)
16) F 1147-99, Standard Test Method for Tension Testing of Calcium Phosphate and
Metallic Coatings
17) F 1160-98, Standard Test Method for Shear and Bending Fatigue Testing of Calcium
Phosphate and Metallic Medical Coatings
18) F 1377-98a, Standard Specification for Cobalt-28 Chromium-6 Molybdenum
Powder for Coating of Orthopedic Implants UNS R30075
19) F 1440-92 (97), Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip
Arthroplasty Femoral Components Without Torsion
20) F 1472-99, Specification for Wrought Titanium - 6 Aluminum - 4 Vanadium Alloy
for Surgical Implant Applications (UNS R56400)
2 1) F 1537-94, Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy
for Surgical Implants
22) F 1580-95, Standard Specification for Titanium and Titanium-6% Aluminum-4%
Vanadium Alloy Powders for Coatings of Surgical Implants
23) F 1612-95, Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip
Arthroplasty Femoral Components with Torsion
24) F 18 14-97a, Standard Guide for Evaluating Modular Hip and Knee Joint
Components
25) F 1820-97, Standard Test Method for Determining the Axial Disassembly Force of a
Modular Acetabular Device
26) F 1854-98, Test Method for Stereological Evaluation of Porous Coatings on Medical
Implants
27) F 1978-00, Test Method for Measuring Abrasion Resistance of Metallic Thermal
Spray Coatings by Using the TaberTMAbraser

b. International Organization for Standardization (ISO) Consensus Standards:

1) IS0 5832-1997, Implants for Surgery - Metallic Materials - Part 1: Wrought

Stainless Steel
2) IS0 5832-1996, Implants for Surgery - Metallic Materials - Part 3: Wrought
Titanium 6-Aluminium 4-Vanadium Alloy
3) IS0 5832-1996, Implants for Surgery - Metallic Materials - Part 4: Cobalt-
Chromium-Molybdenum Casting Alloy
4) IS0 5832-1992, Implants for Surgery - Metallic Materials - Part 9: Wrought High
Nitrogen Stainless Steel
5) IS0 7206-1989, Implants for Surgery - Partial and Total Hip Joint Prostheses - Part
4: Determination of Endurance Properties of Stemmed Femoral Components with
Application of Torsion
6) IS0 7206-1995, Implants for Surgery Partial and Total Hip Joint Prostheses -Part 8:
Endurance Performance of Stemmed Femoral Components with Application of
Torsion

3. Labeling

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 Draft-Not for Implementation

a. Intended Use/ Indications for Use:

The hip joint metal/polymer constrained cemented or &cemented prosthesis is intended

to replace a hip joint. The device is intended for primary or revision patients at high risk
of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity,
neuromuscular disease, or intra-operative instability and for whom all other options to
constrained acetabular components have been considered.

b. Precautions:

(1) When using metallic cups intended for biological fixation or cemented use only,
surgeons should consider providing immediate resistance to tensile forces between the
metallic cup and the acetabular bone through the use of bone screws, spikes, screw
threads, fins, etc.

(2) To correctly position the metallic locking ring, surgeons should consult the
manufacturers instructions for appropriate device assembly.

(3) Physicians should consider component malposition, component placement, and.the

effect on range of motion when using modular heads (with sleeves or skirts) and
extended liners.

page 5
DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. ' ]

Medical Devices: Draft Guidance; Class II Special Controls

Guidance Document: Hip Joint Metal/Polymer Constrained

Cemented or Uncemented Prosthesis; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing

the avai lability of the draft guidance entitled, "Class II

j
Special Controls Guidance Document: Hip Joint Metal/Polymer

Constrained Cemented or Uncemented Prosthesis." This guidance

document was developed as a special control guidance to

support the re'classification of the hip joint metal/polymer

constrained cemented or uncemented prosthesis into class II.

This guidance is not final nor is it in effect at this time.

DATES: Submit written comments concerning this guidance by

[Insert the date 90 days after,date of publication in the

FEDERAL REGISTER].

ADDRESSES: Submit written comments concerning this guidance

to the Dockets Management Branch (HFA-305),.Food and Drug

Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD

20852. Comments are to be identified with the docket number

found in the brackets in the heading of this document. Submit

 _ .,....-. ---l_.- ..-- ~~
~, _ i

3
I

SUPPLEMENTARY INFORMATION section for information on

electronic access to the guidance. Submit written requests

for single copies on a 3.5" diskette of the draft guidance

document entitled, "Class II Special Controls Guidance

Document: Hip Joint Metal/Polymer Constrained Cemented or

Uncemented Prosthesis" to the Division of Small Manufacturers

Assistance (HFZ-220), Center for Devices and Radiological

Health, Food and Drug Administration, 1350 Piccard Dr.,

Rockville, MD 20850. Send two self-addressed adhesive.labels

to assist that office in processing your request, or fax your

request to 301-443-8818.

FOR FURTHER INFORMATION CONTACT:

John S. Goode,

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

This draft guidance document was developed as a special

control guidance to support the reclassification of the hip

joint metal/polymer constrained cemented or uncemented

Prosthesis into class II. This guidance will be issued in

conjunction with a FEDERAL REGISTER notice announcing the

proposal to reclassify this device type. This draft

guidance may not be implemented until the reclassification

process undergoes notice and comment and completes final

rulemaking to reclassify this device. If a final rule to

reclassify this device type is not issued, this guidance

document will not be issued as a special control.

FDA believes that special controls, when. combined with

the general controls, will be sufficient to provide

reasonable assurance of the safety and effectiveness of the

hip joint metal/polymer constrained cemented or uncemented

prosthesis. If the device is reclassified, a manufacturer

who intends to,market a. device of this generic type must (1

conform with the general controls of the Federal Food, Drug

and Cosmetic Act (the act ), including the premarket

not ification requirements described in FDA regulations (21

CFR 807.81), (2) address the specific risks to health

associated with the hip joint metal/polymer constrained

cemented or uncemented prosthesis, and (3) receive a

substantial equivalence determination from FDA prior to

marketing the device.

This special control guidance document identifies the

classification, product code, and classification definition

for the generic hip joint metal/polymer constrained cementel

or uncemented prosthesis. In addition, it identifies the

risks to health and serves as a special control that, when

+
4

followed and combined with the general controls, will

generally address the risks associated with this generic

device type and lead to a.timely 510(k) review and

clearance.

II. Significance of Gu idance

This draft guidance document represents the agency's

current thinking about the hip joint metal/polymer constra ined

cemented or uncemented prosthesis. It does not create or

confer any rights for or on any person and does not operate to

bind FDA or the public. An alternative approach may be used

if such approach satisfies the applicable statute and

regulations.

The agency has adopted Good Guidance Practices (GGPs),

and published the final rule, which set forth the agency's

regulations for the development, issuance, and use of guidance

documents (65 FR 56468, September 19, 2000). This draft

guidance document is issued as a Level 1 guidance in

accordance with the GGP regulations.

III. ELECTRONIC ACCESS

In order to receive "Class II Special Controls Guidance

Document: Hip Joint Metal/Polymer Constrained Cemented or

Uncemented Prosthesis".via your fax machine, call the CDRH

Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a

touch-tone telephone. Press 1 to enter the system. At the

second voice prompt press 1 to order a document. Enter the

, P

5 /

document number (1328) followed by the pound sign (#). Follow

the remaining voice prompts to complete your request.

Persons interested 'in obtaining a copy of the draft

guidance may also do so using the Internet. CDRH maintains an

entry on the Internet for easy access to information including

text, graphics, and files that may be downloaded to a personal

computer with Internet access. Updated on a regular basis,

the CDRH home page includes the civil money penhlty guidance

documents'package, device safety alerts, FEDERAL REGISTER

reprints, information on premarket submissions (including

lists of approved applications and manufacturers' addresses),

small manufacturers" assistance, information on video

conferencing and electronic submissions, Mammography Matters,

and other device-oriented information. The CDRH home page may

be accessed at http: //www. fda.gov/cdrh. Guidance documents

are also available on the Dockets Management Branch Internet

site at http:/, 'iwww.fda.govlGhrms/~Ock~ts/default.htm.

VI. Comments

Interested persons may, on or before [Insert date 90 days

after date of publication in the FEDERAL REGISTER], submit to

Dockets Management Branch (address above) written comments

regarding this draft guidance. Submit two copies of any

comments, except that individuals'may submit one copy.

Comments are to be identified with the docket number found in

brackets in the heading pf this document,. The guidance

 6

document and received comments are available for public

examination in the Dockets Management Branch between 9 a.m.

and 4 p.m., Monday through Friday.

DATED: