SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT

K980138 · Spectrum Designs, Inc. · FWP · Apr 3, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980138
• Device Name: SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT
• Applicant: Spectrum Designs, Inc.
• Product Code: FWP · General, Plastic Surgery
• Decision Date: Apr 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spectrum Designs Symmetrical Chin Implant is intended to augment or reconstruct the mandibular or chin area of the face.

Device Story

Solid silicone elastomer implant designed for surgical augmentation or reconstruction of the mandibular or chin area. Surgeon creates a pocket intraorally or extraorally to house the prosthesis. Device provides structural volume to the chin. Used in clinical settings by surgeons. Potential complications include implant displacement, positioning errors, tissue necrosis, bone resorption, fibrous encapsulation, infection, and neural damage.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Solid silicone elastomer; internal facial prosthesis; dimensions/form factor specific to chin anatomy; non-active device.

Indications for Use

Indicated for patients requiring augmentation or reconstruction of the mandibular or chin area of the face. Contraindicated in the presence of 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

Submission Summary (Full Text)

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K980138

3 1998 APR

# SUMMARY OF SAFETY AND EFFECTIVENESS

## SPECTRUM DESIGNS INC. SYMMETRICAL CHIN IMPLANT 510K SUMMARY

#### 1. Submitter's Data

Spectrum Designs Inc. 5921 C Matthews Street Goleta, CA 93117

Contact Person: Telephone: Date Prepared:

Jim Dishman 805 681 4899 December 30, 1997

#### 2. Device Name, Classification

Name: Spectrum Designs Symmetrical Chin Implant FDA Classification: Class II, Prosthesis, Chin, Internal, Classification Number 79FWP, 21 CFR 879.3550

### 3. Identification of Substantially Equivalent Devices Spectrum Designs Meniscus Chin Implant

#### 4. Device Description

Spectrum Designs Symmetrical Chin Implant is manufactured from solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton.

#### 5. Indications for Use

The Spectrum Designs Symmetrical 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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1698 APR

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

K980138 Re: Spectrum Designs Symmetrical Chin Implant Trade Name: Regulatory Class: II Product Code: FWP December 30, 1997 Dated: Received: January 15, 1998

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, Drug, 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 requlations.

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Paqe 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,

Colla M. Witton, Ph.D., M

Cella 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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Include the following "Indications For Use" page that contains the applicant's name, name of the device and the intended use of the device. The information, data and labeling claims in the entire 510(k) submission must support and agree with the "indications for use" statement.

*For a new submission, do NOT fill in the 510(k) number blank.

#### INDICATIONS FOR USE

Applicant: Spectrum Designs, Inc.

980138 * 510(k) Number (if known):

Device Name: Spectrum Designs Symmetrical Chin Implant

Indications For Use

The Spectrum Designs Symmetrical Chin Implant is intended 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) | |
|------------------------------------------------------|----------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | 12980138 |

Prescription Use Per 21 CFR 801.109

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