GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X

K052504 · Implantech Associates, Inc. · MIB · Nov 4, 2005 · Ear, Nose, Throat

Device Facts

• Record ID: K052504
• Device Name: GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X
• Applicant: Implantech Associates, Inc.
• Product Code: MIB · Ear, Nose, Throat
• Decision Date: Nov 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gluteal Implants (Silicone Carving Blocks) are for augmentation and reconstructive surgery. The Implantech Gluteal Implants are carvable to allow the surgeon to shape the device should additional shaping be desired.

Device Story

Gluteal implants consist of silicone carving blocks; intended for surgical implantation to augment or reconstruct gluteal tissue. Device is carvable, allowing surgeons to customize shape intraoperatively to meet specific patient anatomical requirements. Used by surgeons in clinical/surgical settings. Provides physical volume enhancement for cosmetic or reconstructive purposes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Silicone carving blocks; solid silicone material; carvable form factor for surgical customization.

Indications for Use

Indicated for patients undergoing gluteal augmentation or reconstructive surgery.

Regulatory Classification

Identification

Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.

Submission Summary (Full Text)

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle with three lines representing its wings or feathers. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 4 2005

Stephen Meade Implantech Associates, Inc. 6025 Nicolle Street, Suite B Ventura, California 93003

Re: K052504

Trade/Device Name: Gluteal Implant Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: II Product Code: MIB Dated: September 9, 2005 Received: September 15, 2005

Dear Mr. Mcade:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencics. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

## Page 2 - Stephen Meade

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icher with anow you to other maing of substantial equivalence of your device to a legally premaired 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), please If you desire specific advice 10. Jour 2010) 276-0120. Also, please note the regulation entitled, Connact the Office of Commarket notification" (21CFR Part 807.97). You may obtain Missuranding Uy reference to prementonibilities under the Act from the Division of Small other general miormational and Consumer Assistance at its toll-free number [phone] or Manufacturers; International and obress http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buehrn
fo

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

510(k) Number (if known):

K052504

Device Name:

Gluteal Implant

Indications For Use:

The Gluteal Implants (Silicone Carving Blocks) are for augmentation and reconstructive surgery. The Implantech Gluteal Implants are carvable to allow the surgeon to shape the device should additional shaping be desired.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

barbare Buehup
(Division Sign Off)

Division of General, Restorative, and Neurological Devices

**510(k) Number** K052504

Page 1 of