GRAFT HARVESTING SAWBLADES

K971978 · Wrightmedicaltechnologyinc · GFA · Jun 18, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971978
• Device Name: GRAFT HARVESTING SAWBLADES
• Applicant: Wrightmedicaltechnologyinc
• Product Code: GFA · General, Plastic Surgery
• Decision Date: Jun 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Graft Harvesting Sawblades are indicated for use as a power accessory in surgical procedures where it is necessary to cut a circular bone plug.

Device Story

Graft Harvesting Sawblade is a circular, two-piece, oscillating surgical sawblade; designed to cut precision circular bone plugs (9-11 mm diameter, 20-30 mm length). Device functions as a power accessory for use with compatible third-party surgical power equipment. Supplied sterile for single use or nonsterile for resterilization. Operated by surgeons in clinical/surgical settings to harvest bone grafts. Output is a physical bone plug used for grafting procedures; assists surgeons in bone harvesting tasks.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Circular, two-piece, oscillating sawblade design. Dimensions: 9-11 mm diameter, 20-30 mm length. Compatible with third-party surgical power equipment. Supplied sterile (single use) or nonsterile (resterilizable).

Indications for Use

Indicated for use as a power accessory in surgical procedures requiring the cutting of a circular bone plug.

Regulatory Classification

Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Predicate Devices

• Stryker Sawblade

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a stylized letter "W" logo. The "W" is formed by three thick, black, inverted triangles arranged side by side. The logo has a simple, geometric design and is presented in black and white. A registered trademark symbol is located to the bottom right of the logo.

Image /page/0/Picture/1 description: The image shows the text "WRIGHT MEDICAL TECHNOLOGY, INC." in a bold, sans-serif font. Below this, the address "5677 AIRLINE ROAD ARLINGTON, TN 38002" is printed. The phone number "901-867-9971" is at the bottom of the image.

K 971978

JUN 18 1997

## 510(k) Summary

Contact Person: Cristie Manuel Date Prepared: May 28, 1997

Trade/Proprietary Name: Common Name: Product Classification: Predicate Devices:

Graft Harvesting Sawblade Surgical instrument motors and accessories/attachments Class I Stryker Sawblade

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

## Description/Intended Use

The Graft Harvesting Sawblade is a circular, two-piece, oscillating harvesting sawblade r no Greate a precision circular bone plug 9-11 mm in diameter by 20-30 mm in length. The sawblades will be supplied either sterile for single use, or nonsterile and resterilizable. The Graft Harvesting Sawblade is used with power equipment available from other manufacturers, and is certified by the supplier to work with the power source.

The Graft Harvesting Sawblades are indicated for use as a power accessory in surgical procedures where it is necessary to cut a circular bone plug.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human profile, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1555 8 1 Nin

Ms. Cristie Manuel Regulatory Affairs Associate Wright Medical Technology, Inc. . . . . 5677 Airline Road Arlington, Tennessee 38002

જ્ Re:

K971978 Trade Name: Graft Harvesting Sawblades Regulatory Class: I Product Code: GFA Dated: May 28, 1997 Received: May 29, 1997

Dear Ms. Manuel:

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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

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Page 2 - Ms. Cristie Manuel

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 attvertising of vour 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,

Sincerely yours,

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

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Wright Medical Technology, Inc. Premarket Notification Graft Harvesting Sawblades

Indications for Use of the Device C.

510(k) Number (if known):_

Graft Harvesting Sawblades Device Name:

*

*

*

Indications for Use:

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ಿಗಳಿಗೆ ಸ್ಟ್ರೀ ಗ್ರಾಮದಿಸ

The Graft Harvesting Sawblades are indicated for use as a power accessory in surgical procedures where it is necessary to cut a circular bone plug.

> (Please do not write below this line-continue on another page if needed) * 水 * * *

## Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Division Sign-Off)
Division of General Restorative Devices K971578
510(k) Number

Or

Prescription Use_X_

(Per 21 CFR 801.109)

Over-the-Counter Use_

(Optional Format 1-2-96)

000009