SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT

K980463 · Spectrum Designs, Inc. · FWP · May 6, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980463
• Device Name: SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT
• Applicant: Spectrum Designs, Inc.
• Product Code: FWP · General, Plastic Surgery
• Decision Date: May 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spectrum Designs Curvilinear Chin Implant is a silicone facial implant, designed to augment or reconstruct the mandibular or chin area of the face.

Device Story

The Spectrum Designs Curvilinear Chin Implant is a solid silicone elastomer prosthesis used for facial augmentation or reconstruction of the chin/mandibular area. It is provided non-sterile in three sizes. The device is implanted by a surgeon during a clinical procedure. The implant provides structural support to the chin area to improve aesthetics or reconstruct anatomy. Potential benefits include improved facial contour; however, risks include displacement, tissue necrosis, bone resorption, fibrous encapsulation, infection, and neural damage.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manufactured from medical grade solid silicone elastomer. Available in three sizes. Non-sterile. Class II device (21 CFR 878.3550).

Indications for Use

Indicated for patients requiring augmentation or reconstruction of the mandibular or chin area of the face. Contraindicated in patients with active infection anywhere in the body, specifically in the region of implantation.

Regulatory Classification

Identification

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

Predicate Devices

• Spectrum Designs Meniscus Chin Implant
• McGhan Medical Corp. Geniomandibular Groove Chin/Jowl Implant

Submission Summary (Full Text)

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K980463

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#### SUMMARY OF SAFETY AND EFFECTIVENESS

#### SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT MAY 6 1898

### 510K SUMMARY

- 1. Submitter's Data
Spectrum Designs Inc. 5921 C. Matthews Street Goleta, CA 93117

Contact Person: Jim Dishman [phone] Telephone: Date Prepared: December 30, 1997

### 2. Device Name, Classification

Name: Spectrum Designs Curvilinear Chin Implant FDA Classification: Class II, Prosthesis, Chin, Internal, Classification Number 79FWP, 21 CFR 878.3550

# 3. Identification of Substantially Equivalent Devices

Spectrum Designs Meniscus Chin Implant McGhan Medical Corp. Geniomandibular Groove Chin/Jowl Implant

## 4. Device Description

The Spectrum Designs Curvilinear Chin Implant is manufactured from medical grade solid silicone elastomer. It is provided non-sterile and available in three sizes.

# 5. Indications for Use

The Spectrum Designs Curvilinear Chin Implant is a silicone facial implant, designed to augment or reconstruct the mandibular or chin area of the face.

### 6. Contraindications for Use

Contraindications for routine aesthetic surgery include the presence of infection anywhere in the body and in particular, in the region in which the device will be implanted.

## 7. Warnings, Precautions

Possible complications include:

- Displacement of the implant may occur, especially from dissection of too large a . pocket.
- Errors in positioning the implant may result in patient dissatisfaction .
- Tissue necrosis may result in extrusion of the implant. This can occur as a result . of such factors as the pocket created being too small, use of too large an implant, or when soft tissues are inadequate to maintain coverage over the prosthesis
- Resorption of the underlying bone may occur with use of the implant. ◆
- Fibrous tissue encapsulation can occur around any implant, with subsequent ● increased firmness, possible displacement, and/or pains.
- Complications from this or any similar surgery may include infection, neural ● damage, hematoma, poor would healing, patient intolerance to foreign body implantation, and other similar complications.

.5

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized eagle emblem. The eagle is depicted with three lines forming its head and body, symbolizing the department's mission related to health and human well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY _ 6 1998

Mr. Jim Dishman ·Spectrum Designs, Incorporated 5921-C Matthews Street Goleta, California 93117

K980463 Re: Spectrum Designs Curvilinear Chin Implant Trade Name: Requlatory Class: ı i Product Code: FWP Dated: January 12, 1998 February 5, 1998 Received:

Dear Mr. Dishman:

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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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. ति substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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 In addition, FDA may publish further announcements action. 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.

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#### Page 2 - Mr. Dishman

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/dsmamain.html".

Sincerely yours,

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

Enclosure

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# INDICATIONS FOR USE

Applicant: Spectrum Designs, Inc.

510(k) Number (if known): _

Device Name: Spectrum Designs Curvilinear Chin Implant Indications for Use

The Spectrum Designs Curvilinear Chin Implant is a silicone facial implant, designed to augment or reconstruct the mandibular or chin area of the face.

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

# Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR 801.109

OL

Over-the counter

P. Catella

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(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K980463