[Federal Register Volume 62, Number 125 (Monday, June 30, 1997)]
[Notices]
[Pages 35213-35214]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16968]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food And Drug Administration
[Docket No. 97M-0252]


Sulzer Orthopedics, Inc.; Premarket Approval of the 
Natural Knee and Natural Knee II with Cancellous Structured 
Titanium (CSTiTM)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
approval of the application submitted by Sulzer Orthopedics, 
Inc., Austin, TX, for premarket approval, under the Federal Food, Drug, 
and Cosmetic Act (the act), of the Natural Knee and Natural 
Knee II with Cancellous Structured Titanium 
(CSTiTM). After reviewing the recommendation of the 
Orthopedic and Rehabilitation Devices Panel, FDA's Center for Devices 
and Radiological Health (CDRH) notified the applicant, by letter of 
March 21, 1997, of the approval of the application.

DATES: Petitions for administrative review by July 30, 1997.

ADDRESSES: Written requests for copies of the summary of safety and 
effectiveness data and petitions for administrative review to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

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


[[Page 35214]]


SUPPLEMENTARY INFORMATION: On April 27, 1995, Sulzer 
Orthopedics, Inc., Austin, TX 78717, submitted to CDRH an 
application for premarket approval of the Natural Knee and 
Natural Knee II with CSTiTM. These devices are 
biologically fixed total knee prostheses and are indicated for 
uncemented use in skeletally mature individuals with intact medial and 
lateral collateral ligaments undergoing primary surgery for 
rehabilitating knees damaged as a result of Noninflammatory 
Degenerative Joint Disease or Inflammatory Joint Disease.
    On June 12, 1995, the Orthopedics and Rehabilitation Devices Panel 
of the Medical Devices Advisory Committee, an FDA advisory committee, 
reviewed and recommended approval of the application.
    On March 21, 1997, CDRH approved the application by a letter to the 
applicant from the Director of the Office of Device Evaluation, CDR
    A summary of the safety and effectiveness data on which CDRH based 
its approval is on file in the Dockets Management Branch (address 
above) and is available from that office upon written request. Requests 
should be identified with the name of the device and the docket number 
found in brackets in the heading of this document.

Opportunity For Administrative Review

    Section 515(d)(3) of the act (21 U.S.C. 360e(d)(3)) authorizes any 
interested person to petition, under section 515(g) of the act, for 
administrative review of CDRH's decision to approve this application. A 
petitioner may request either a formal hearing under part 12 (21 CFR 
part 12) of FDA's administrative practices and procedures regulations 
or a review of the application and CDRH's action by an independent 
advisory committee of experts. A petition is to be in the form of a 
petition for reconsideration under 21 CFR 10.33(b). A petitioner shall 
identify the form of review requested (hearing or independent advisory 
committee) and shall submit with the petition supporting data and 
information showing that there is a genuine and substantial issue of 
material fact for resolution through administrative review. After 
reviewing the petition, FDA will decide whether to grant or deny the 
petition and will publish a notice of its decision in the Federal 
Register. If FDA grants the petition, the notice will state the issue 
to be reviewed, the form of the review to be used, the persons who may 
participate in the review, the time and place where the review will 
occur, and other details.
    Petitioners may, at any time on or before July 30, 1997, file with 
the Dockets Management Branch (address above) two copies of each 
petition and supporting data and information, identified with the name 
of the device and the docket number found in brackets in the heading of 
this document. Received petitions may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.
     This notice is issued under the Federal Food, Drug, and Cosmetic 
Act (secs. 515(d), 520(h) (21 U.S.C. 360e(d), 360j(h))) and under 
authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10) 
and redelegated to the Director, Center for Devices and Radiological 
Health (21 CFR 5.53).

    Dated: June 5, 1997.
 Joseph A. Levitt,
 Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-16968 Filed 6-27-97; 8:45 am]
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