SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT

K980445 · Spectrum Designs, Inc. · FWP · May 6, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980445
• Device Name: SPECTRUM DESIGNS CONCAVE BACK 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 Concave Back Chin Implant is intended to augment or reconstruct congenital or traumatic chin deficiencies.

Device Story

The Spectrum Designs Concave Back Chin Implant is a solid silicone elastomer prosthesis designed for surgical augmentation or reconstruction of the chin. It is implanted by a surgeon via an intraoral or extraoral approach into a pocket created in the mandibular region. The device is provided non-sterile in six sizes. By providing structural volume to the chin, the implant addresses aesthetic or functional deficiencies caused by congenital factors or trauma. Clinical outcomes depend on proper surgical pocket creation and positioning; potential risks include displacement, tissue necrosis, bone resorption, fibrous encapsulation, and infection.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Medical grade solid silicone elastomer; six available sizes; non-sterile; passive implantable prosthesis.

Indications for Use

Indicated for patients requiring augmentation or reconstruction of chin deficiencies resulting from congenital conditions or trauma. 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

• McGhan Medical Corp. Concave Back Chin Implant

Submission Summary (Full Text)

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6 1998 MAY

## SUMMARY OF SAFETY AND EFFECTIVENESS

# SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT 510K SUMMARY

K980445

## 1. Submitter's Data

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

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

## 2. Device Name, Classification

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

## 3. Identification of Substantially Equivalent Devices

McGhan Medical Corp. Concave Back Chin Implant

### 4. Device Description

The Spectrum Designs Concave Back Chin Implant is manufactured from medical grade 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. It is provided non-sterile and available in six sizes.

#### 5. Indications for Use

The Spectrum Designs Concave Back Chin Implant is a silicone facial implant, designed to augment or reconstruct congenital or traumatic chin deficiencies.

#### 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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design, with three wavy lines representing the department's mission of promoting health and well-being.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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C 1698 MAY

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

Re : K980444 Bilateral Groove Chin Implant Trade Name: K980445 Concave Back Chin Implant Trade Name: K980446 Anterior Chin Implant Trade Name: Regulatory Class: II Product Code: FWP Dated: January 17, 1998 Received: February 5, 1998

Dear Mr. Dishman:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, subject to the qeneral 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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

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#### Page 2 - Mr. Dishman

In addition, FDA may publish further announcements action. concerning your devices 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.

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

If you desire specific advice for your devices 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 devices, 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".

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Sincerely yours,

Aristotle

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

Enclosures

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## INDICATIONS FOR USE

Applicant: Spectrum Designs Inc.

x980445 510(k) Number ( if known):

Device Name: Spectrum Designs Concave Back Chin Implant

Indications for Use:

The Spectrum Designs Concave Back Chin Implant is intended to augment or reconstruct congenital or traumatic chin deficiencies.

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

| Concurrence of CDRH Office of Device Evaluation (ODE) | |
|-------------------------------------------------------|-----------------------------|
| Prescription use<br>Per 21 CFR 801.109 | X |
| or | Over-the counter __________ |

(Division Sign-Off)

Division of General Restorative Devices

| 510(k) Number | K980445 |
|---------------|---------|
|---------------|---------|

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