SURGIFORM ANATOMICAL MALAR

K983756 · Surgical Technology Laboratories, Inc. · LZK · Nov 20, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K983756
• Device Name: SURGIFORM ANATOMICAL MALAR
• Applicant: Surgical Technology Laboratories, Inc.
• Product Code: LZK · General, Plastic Surgery
• Decision Date: Nov 20, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Surgiform Anatomical Malar implants can be used by surgeons in a unique surgical procedure designed to restore or enhance a patients facial appearance. The implants can be used for aesthetic or reconstructive procedures. The implants can be inserted into a "pocket" created by means of a standard intraoral surgical incision. The implants can elevate and reposition sagging skin and can also fill the hollows and depressions caused by gravity and time. The implants can also be used by surgeons to restore a patients natural appearance as a result of severe facial trauma.

Device Story

Surgiform Anatomical Malar implant is a solid facial implant used by surgeons to restore or enhance facial contours. Device is inserted into a surgically created pocket via standard intraoral incision. Implant elevates sagging skin and fills hollows/depressions caused by aging or trauma. Used in aesthetic or reconstructive surgical procedures. Provides structural support to facial tissues to improve patient appearance.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Solid facial implant; intended for surgical implantation via intraoral incision. Specific material composition and ASTM standards not provided in the document.

Indications for Use

Indicated for patients requiring facial aesthetic or reconstructive procedures, including restoration of appearance following severe facial trauma, or correction of hollows, depressions, and sagging skin associated with aging.

Regulatory Classification

Identification

A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a bold, sans-serif font. The words are arranged horizontally, with 'Public' and 'Health' on the first line and 'Service' on the second line.

Image /page/0/Picture/11 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

## NOV 20 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Richard T. Nock Vice President Surgical Technology Laboratories, Inc. 1588 East 40th St. Cleveland, Ohio 44103

Re: K983756

Trade Name: Surgiform Anatomical Malar Regulatory Class: II Product Code: LZK Dated: October 16, 1998 Received: October 22, 1998

Dear Mr. Nock:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{1}------------------------------------------------

Page 2 - Mr. Richard T. Knock

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Acooley

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

19 11:36 SURGIFORM

Image /page/2/Picture/1 description: The image shows the logo for Surgical Technology Laboratories, Inc. The logo is black and white and features the company name in a bold, sans-serif font. Below the company name is the address: 1588 East 40th St. Cleveland, Ohio 44103. The logo is simple and professional.

Image /page/2/Picture/2 description: The image shows a series of bold, black brushstrokes that appear to form characters or symbols. The strokes vary in thickness and direction, creating a dynamic and expressive composition. The characters are spaced irregularly, with some strokes connecting to form more complex shapes. The overall effect is abstract and calligraphic, suggesting a stylized or artistic representation of text.

[phone]

510(k) Number (if known): K 983756

Device Name: Surgiform Anatomical Malar Implant

## Indications for Use:

Surgiform Anatomical Malar implants can be used by surgeons in a unique surgical procedure designed to restore or enhance a patients facial appearance. The implants can be used for aesthetic or reconstructive procedures. The implants can be inserted into a "pocket" created by means of a standard intraoral surgical incision. The implants can elevate and reposition sagging skin and can also fill the hollows and depressions caused by gravity and time. The implants can also be used by surgeons to restore a patients natural appearance as a result of severe facial trauma.

Acoole

Prescription Use
(Per 21 CFR 801.109)