ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM

K994202 · Smith & Nephew, Inc. · HWC · Feb 25, 2000 · Orthopedic

Device Facts

• Record ID: K994202
• Device Name: ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Feb 25, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Acufex® Washer Systems are indicated for fixation of soft tissue, such as tendons and ligaments to bone in orthopedic procedures.

Device Story

Acufex® Washer Systems consist of titanium screws and washers (polyacetal with titanium ring or all-titanium) used for soft tissue-to-bone fixation in orthopedic surgery. Screws range 4.5-9 mm diameter and 18-70 mm length; washers feature spikes for bone engagement and holes for suture-tendon construct security. Operated by surgeons in clinical/OR settings. Device provides mechanical fixation to stabilize soft tissue, facilitating healing. Output is physical stabilization of tissue construct.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Titanium, polyacetal polymer. Configuration: Cancellous screw (4.5-9 mm diameter, 18-70 mm length) and spiked washer (13-22 mm outer diameter). Mechanical fixation principle. Sterile or non-sterile, single-use.

Indications for Use

Indicated for fixation of soft tissue, including tendons and ligaments, to bone during orthopedic procedures.

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.

Predicate Devices

• Acufex® Tibial Anchor Screw and Spiked Washer (K961649)
• DePuy OrthoTech Soft Tissue Fixation Washer (K910229)

Submission Summary (Full Text)

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K994202 1

### VI. 510K Summary and Truthful and Accurate Statement

## 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is :

This summary was prepared on December 10, 1999.

#### A. Submitter

Smith & Nephew, Inc., Endoscopy Division 130 Forbes Boulevard Mansfield, MA 02048

#### B. Company Contact

Nicholas Condakes Regulatory Affairs Specialist

#### C. Device Name

| Proprietary Name: | Acufex® Spiked Washer System<br>Acufex® Suture Washer System<br>Acufex® Cancellous Screw and Spiked Suture Washer<br>System |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Soft Tissue Fixation Screw and Washer |
| Classification Name: | Single/multiple component metallic bone fixation<br>appliances and accessories |
| Product Code: | Screw: HWC<br>Washer: HTN |
| Regulatory Class: | The Orthopedic Device Panel has classified Screws and<br>Washers as a Class II device (21 CFR § 888.3030) |

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#### D. Predicate/Legally Marketed Devices

Acufex® Tibial Anchor Screw and Spiked Washer (K961649): Smith + Nephew Inc., Endoscopy Division 130 FORBES BLVD MANSFIELD, MA 02048

DePuy OrthoTech Soft Tissue Fixation Washer (K910229) DePuy OrthoTech, Inc.

20F 3

700 Orthopaedic Drive Warsaw, IN 46581

and and the Mark of the Promoted

#### Device Description E.

VI.

The Acufex® Washer Systems are used in fixation of soft tissue to bone. The systems include various style polyacetal (with a titanium ring) or titanium washers and titanium screws. The screws are available with a diameter range from 4.5 to 9 mm and 18 to 70 mm in length. Various washers have spikes to engage to bone. Suture spiked washers are designed with spikes for engagement to bone and suture holes to secure suture tendon construct. Also, suture washers are used to secure suture tendon construct to bone.

#### F. Indications for Use

The Acufex® Washer Systems are used for fixation of soft tissue, such as to hono quinno orthonodio provodio provoditor tondana and linamonto

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# 510K Summary and Truthful and Accurate Statement

#### G. Substantial Equivalence

VI.

| | Subject Device<br>Acufex® Washer<br>Systems | Predicate Device<br>Acufex® Tibial<br>Anchor Screw &<br>Spiked Washer<br>(K961649) | Predicate Device<br>DePuy OrthoTech Soft<br>Tissue Fixation<br>Washer<br>(K910229) |
|------------------------|-----------------------------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| DESIGN | | | |
| Screw<br>Configuration | Cancellous | Cancellous | Cancellous |
| Screw size | Screw length<br>18 - 70 mm | Screw length<br>18 - 30 mm | Screw length 25-65 mm |
| | Screw diameter 4.5 - 9 mm | Screw diameter<br>7 - 9 mm | Screw diameter 6.5 mm |
| Washer size | Outer diameter 13 - 22 mm | Outer diameter<br>14 - 20 mm | Outer diameter<br>14 - 20 mm |
| INDICATIONS<br>FOR USE | | | |
| | Soft tissue fixation | Soft tissue fixation | Soft tissue fixation |
| MATERIALS | | | |
| Screw | Titanium | Titanium | Titanium |
| Washer | Titanium reinforced,<br>Polyacetal polymer<br>Or Titanium | Titanium reinforced,<br>Polyacetal polymer | Titanium |
| LABELING | | | |
| Screw | Sterile, Single Use Only/<br>Non-Sterile, Single Use | Sterile, Single Use Only/<br>Non-Sterile, Single Use | Sterile, Single Use Only |
| Washer | Sterile, Single Use Only /<br>Non-Sterile, Single Use | Sterile, Single Use Only | Sterile, Single Use Only |

199 Applicant ____________________________________________________________________________________________________________________________________________________________________ Date / 2 ousliker

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three wavy lines representing snakes or streams.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 2000

Mr. Nicholas Condakes Regulatory Affairs Specialist SMITH & NEPHEW, INC. 130 Forbes Boulevard Mansfield, Massachusetts 02048

Re: K994202 Trade Name: Acufex® Washer System Regulatory Class: II Product Code: HWC and HTN Dated: December 10, 1999 Received: December 13, 1999

Dear Mr. Condakes:

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 control provisions of the Act. The general control 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.

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.

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## Page 2 - Mr. Nicholas Condakes

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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Ronald Reagan

Sor James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known) Device Name Indications For Use:

K994202

Acufex® Washer Systems

The Acufex® Washer Systems are indicated for fixation of soft tissue, such as tendons and ligaments to bone in orthopedic procedures.

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

X Prescription Use (Per 21 CFR §801.109)

OR

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Darrell Payne

i

Division Sian-C

(Optional Format 1-2-90)