[Federal Register Volume 62, Number 221 (Monday, November 17, 1997)]
[Notices]
[Page 61339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30149]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97M-0459]


Osteonics Corp.; Premarket Approval of the Osteonics Constrained 
Acetabular Insert

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 Osteonics Corp., Allendale, 
NJ, for premarket approval, under the Federal Food, Drug, and Cosmetic 
Act (the act), of the Osteonics Constrained Acetabular Insert. 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 June 13, 1997, of the approval of 
the application.

DATES: Petitions for administrative review by December 17, 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.

SUPPLEMENTARY INFORMATION: On December 16, 1996, Osteonics Corp., 
Allendale, NJ 07401-1677, submitted to CDRH an application for 
premarket approval of the Osteonics Constrained Acetabular Insert. The 
device is a constrained hip and is indicated for use as a component of 
a total hip prosthesis in primary and revision patients at high risk of 
hip dislocation due to a history of prior dislocation, bone loss, joint 
or soft tissue laxity, neuromuscular disease, or intraoperative 
instability.
    On June 10, 1997, the Orthopedic and Rehabilitation Devices Panel 
of the Medical Devices Advisory Committee, an FDA advisory committee, 
reviewed and recommended approval of the application. On June 13, 1997, 
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 Federal Food, Drug, and Cosmetic 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 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 December 17, 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: October 16, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-30149 Filed 11-14-97; 8:45 am]
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