[Federal Register Volume 59, Number 74 (Monday, April 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9307]


[[Page Unknown]]

[Federal Register: April 18, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94M-0062]

 

DePuy, Inc.; Premarket Approval of the Rotating Platform 
Configuration of the New Jersey LCS Total Knee System

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 by DePuy, Inc., Warsaw, IN, for premarket 
approval, under section 515 of the Federal Food, Drug, and Cosmetic Act 
(the act), of the Rotating Platform Configuration of the new jersey 
LCS Total Knee System. 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 February 24, 1994, of the approval of the application.

DATES: Petitions for administrative review by May 18, 1994.

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, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Paul R. Beninger, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 1390 
Piccard Dr., Rockville, MD 20850, 301-594-1184.

SUPPLEMENTARY INFORMATION: On April 26, 1991, DePuy, Inc., Warsaw, IN 
46581-0988, submitted to CDRH an application for premarket approval of 
the Rotating Platform Configuration of the new jersey LCS 
Total Knee System. The device is indicated for uncemented use in 
skeletally mature individuals undergoing primary surgery for 
rehabilitating knees damaged as a result of noninflammatory 
degenerative joint disease (NIDJD) or either of its composite diagnoses 
of osteoarthritis or post-traumatic arthritis. It is indicated for use 
in knees whose anterior and posterior cruciate ligaments are absent or 
are in such condition as to justify sacrifice.
    On November 22, 1991, the Orthopedic and Rehabilitation Devices 
Panel of the Medical Devices Advisory Committee, an FDA advisory 
committee, reviewed and recommended approval of the application. On 
February 24, 1994, CDRH approved the application by a letter to the 
applicant from the Director of the Office of Device Evaluation, CDRH.
    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 (21 
U.S.C. 360e(g)), 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 
Sec. 10.33(b) (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 
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 May 18, 1994, 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: April 5, 1994.
 Joseph A. Levitt,
 Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 94-9307 Filed 4-15-94; 8:45 am]
BILLING CODE 4160-01-F