FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE

K965228 · United States Surgical, A Division of Tyco Healthc · MAI · Nov 10, 1997 · Orthopedic

Device Facts

• Record ID: K965228
• Device Name: FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: MAI · Orthopedic
• Decision Date: Nov 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Surgical Dynamics™ Meniscal Staple is an absorbable implantable device for meniscal tissue approximation. It consists of two resorbable legs connected by a resorbable braid. The device is composed of a polylactic/polyglycolic acid copolymer, which degrades in vivo via hydrolysis into lactic and glycolic acids for metabolic clearance. It is intended for use by surgeons in the repair of specific meniscal tears. The staple provides mechanical fixation to hold tissue edges together during the healing process.

Clinical Evidence

In vitro and in vivo performance testing demonstrated the device is suitable for the approximation of meniscal tissue.

Technological Characteristics

Resorbable staple with braid; material: polylactic/polyglycolic acid copolymer; biosafe materials compliant with ISO Standard #10993-1; absorbable via hydrolysis.

Indications for Use

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

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• PDS II Suture, Ethicon, Inc.

Submission Summary (Full Text)

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Surgical Dynamics™ Meniscal Staple**

K965228

510(k) SUMMARY OF INFORMATION:

NOV 10 1997

SUBMITTER: United States Surgical Corporation
150 Glover Avenue
Norwalk, CT 06856
[phone]

CONTACT PERSON: Craig M. Audet

DATE PREPARED: October 31, 1997

CLASSIFICATION NAME: Fastener, Fixation, Biodegradable Soft Tissue

COMMON NAME: Absorbable Implantable Staple

PROPRIETARY NAME: Trademark name not yet determined.

PREDICATE DEVICE: PDS II Suture, Ethicon, Inc.

DEVICE DESCRIPTION: The Surgical Dynamics™ Meniscal Staple** consists of a resorbable braid connecting the two resorbable legs of the staple. The staple is used in the approximation of soft tissue, specifically the meniscus. The device is made of a resorbable copolymer, a polyester derivative of lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs in vivo by hydrolysis into lactic and glycolic acids which are then metabolized by the body.

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

MATERIALS: All component materials of the Surgical Dynamics™ Meniscal Staple** and stapler are comprised of biosafe materials which are in accordance with ISO Standard #10993-1.

PERFORMANCE TESTING: In vitro and in vivo performance testing demonstrated Surgical Dynamics™ Meniscal Staple is suitable for use in the approximation of meniscal tissue.

K965228

October 31, 1997

United States Surgical Corp.

RA01

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Craig M. Audet
Director, Corporate Regulatory Affairs
United States Surgical Corporation
150 Glover Avenue
Norwalk, Connecticut 06856

NOV 10 1997

Re: K965228
Surgical Dynamics™ Meniscal Staple
Regulatory Class: II
Product Code: MAI
Dated: August 11, 1997
Received: August 14, 1997

Dear Mr. Audet:

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 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 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 - Mr. Craig M. Audet

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,


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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Surgical Dynamics™ Meniscal Staple**

## II. Indications Page:

510(k) Number: K965228

Device Name: Surgical Dynamics™ Meniscal Staple**

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

(Please do not write below this line - continue on another page if necessary)
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: ☑ OR Over-The-Counter Use:


K965228
October 31, 1997
United States Surgical Corp.
RA01
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