SURGICAL DYNAMICS MENISCAL STAPLE

K013890 · United States Surgical, A Division of Tyco Healthc · HWC · Dec 11, 2001 · Orthopedic

Device Facts

• Record ID: K013890
• Device Name: SURGICAL DYNAMICS MENISCAL STAPLE
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: HWC · Orthopedic
• Decision Date: Dec 11, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Surgical Dynamics Meniscal Staple is intended for the repair of vertical longitudinal full thickness tears (i.e., bucket-handle) in the red-red and red-white zones.

Device Story

Absorbable implantable staple for meniscal repair; consists of two rigid resorbable barbed legs connected by a length of resorbable, flexible braided filament. Used by surgeons to facilitate repair of vertical longitudinal full-thickness meniscal tears in vascular zones. Device provides mechanical fixation to hold tissue in place during healing process.

Technological Characteristics

Absorbable polymer construction; two rigid resorbable barbed legs; resorbable flexible braided filament connector.

Indications for Use

Indicated for repair of vertical longitudinal full thickness (bucket-handle) meniscal tears in red-red and red-white zones.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Submission Summary (Full Text)

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# Attachment 4

DEC 1 1 2001

K 013890
page 1 of 1

### 510(k) Summary

#### Surgical Dynamics Meniscal Staple

United States Surgical 150 Glover Avenue Norwalk, CT 06856 USA

#### DEVICE DESCRIPTION

The currently marketed Surgical Dynamics Meniscal Staple is an absorbable implantable staple The ourtency martides bolymer. The staple consists of two rigid resorbable barbed legs connected by a length of resorbable, flexible braided filament. The staple is designed to facilitate meniscal repair in the vascular zone of the meniscus.

#### INDICATIONS FOR USE

The Surgical Dynamics Meniscal Staple is intended for the repair of vertical longitudinal full thickness tears (i.e., bucket-handle) in the red-red and red-white zones.

#### SUBSTANTIAL EQUIVALENCE*

The modified Surgical Dynamics Meniscal Staple was claimed to be substantially equivalent* to the currently marketed version of the device. Information pertaining to this device was provided in the submission.

* Any claim of substantial equivalence is made exclusively in regard to the U.S. Food, Drug and Cosmetic Act and should not be viewed in any other light.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 2001

Ms. Jenny Schuck Regulatory Affairs Senior Associate United States Surgical 150 Glover Avenue Norwalk, Connecticut 06856

Re: K013890

Device Name: Surgical Dynamics Meniscal Staple Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: November 20, 2001 Received: November 23, 2001

Dear Ms. Schuck:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nove 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 for use sured in the encreated 776, the enactment date of the Medical Device Amendments, or to conniner of the 11th 2011-11-11 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 I ou may, alcrever, mains 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 If your device is elassinod (600 as controls. Existing major regulations affecting your device can may or bayer to been 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 r 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 agencies. You must or uny 1 sattail 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 Of It in the quality systems (21 (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.

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Page 2 - Ms. Jenny Schuck

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and my of your finding of substantial equivalence of your device to a legally premarked noutheater - 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of Compliance alease contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division Other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Sincerely yours,

Mark A. Melkerson

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

Enclosure

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### Attachment 2

page lof 1

## Indications for Use Statement

510(k) Number

K013890

Device Name Surgical Dynamics Meniscal Staple

Indications For Use

The Surgical Dynamics Meniscal Staple is intended for the repair of vertical longitudinal full thickness The Durglour Dyl-handle) in the red-red and red-white zones.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| <strong>Labels</strong> | <strong>Values</strong> |
|--------------------------|-------------------------|
| Prescription Use: | Yes |
| (Per 21 CFR 801.109) | |
| OR Over-The-Counter Use: | No |

for Mark N. Melker
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

| <strong>Labels</strong> | <strong>Values</strong> |
|-------------------------|-------------------------|
| 510(k) Number | K013890 |