MINILOK QUICKANCHOR PLUS

K030995 · Mitek Worldwide · HWC · Jun 26, 2003 · Orthopedic

Device Facts

• Record ID: K030995
• Device Name: MINILOK QUICKANCHOR PLUS
• Applicant: Mitek Worldwide
• Product Code: HWC · Orthopedic
• Decision Date: Jun 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MINILOK QuickAnchor Plus is intended for fixation of soft tissue to bone, using suture, for the indications listed below: Ankle: Mid-foot reconstruction Foot: Hallux valgus reconstruction Hand: Ulnar or lateral collateral ligament reconstruction Wrist: Scapholunate ligament reconstruction

Device Story

Preloaded disposable anchor/inserter assembly; facilitates delivery and installation of bone anchor into bone. Used by surgeons in clinical settings for soft tissue-to-bone fixation via suture. Device provides mechanical attachment point for ligaments/tendons during reconstructive procedures of ankle, foot, hand, and wrist. Benefits include secure fixation to support healing and structural restoration.

Clinical Evidence

Bench testing only; biocompatibility studies confirmed device is non-toxic, non-irritating, non-sensitizing, and non-cytotoxic.

Technological Characteristics

Preloaded disposable anchor/inserter assembly. Mechanical bone fixation device. Biocompatible materials.

Indications for Use

Indicated for patients requiring soft tissue to bone fixation during mid-foot, hallux valgus, ulnar/lateral collateral ligament, or scapholunate ligament reconstruction.

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

• Mini QuickAnchor Plus (K930892, K992487, K992623)
• MicroFix QuickAnchor Plus (K0224115)
• Mini Bio-Anchor (K022234)

Submission Summary (Full Text)

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K030995 pge 1/2

# JUN 2 6 2003

## SECTION 2 -- 510(k) SUMMARY

### MINILOK QuickAnchor Plus

| Submitter's Name and<br>Address: | Mitek Worldwide<br>a division of ETHICON Inc.<br>a Johnson & Johnson Company<br>249 Vanderbilt Avenue<br>Norwood, MA 02062 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ruth C. Forstadt<br>Senior Regulatory Affairs Associate<br>Mitek Worldwide<br>a division of ETHICON Inc.<br>a Johnson & Johnson Company<br>249 Vanderbilt Avenue<br>Norwood, MA 02062<br>Telephone: [phone]<br>Facsimile: 781-278-9578<br>e-mail: [e-mail] |
| Name of Medical Device | Classification Name: Fastener, Fixation, Biodegradable, Soft<br>Tissue<br>Common/Usual Name: Bone Anchor<br>Proprietary Name: MINILOK QuickAnchor Plus |
| Substantial Equivalence | MINILOK QuickAnchor Plus is substantially equivalent to:<br>Mini QuickAnchor Plus (K930892, K992487 and K992623) and<br>MicroFix QuickAnchor Plus (K0224115) manufactured by Mitek<br>Worldwide, a division of Ethicon, Inc., a Johnson & Johnson<br>Company, 249 Vanderbilt Avenue, Norwood, MA 02062. In addition,<br>the MINILOK QuickAnchor Plus is substantially equivalent to the<br>absorbable Mini Bio-Anchor, K022234, manufactured by Arthrex,<br>Inc., in Naples, Florida. |
| Device Classification | Bone anchors/screws are classified by FDA as a Class II Medical<br>Devices under the generic category of Single/Multiple Component<br>Metallic Bone Fixation Appliances, Orthopedic Devices Panel<br>(reference 21 CFR §888.3030). Product code MAI. |

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#### The MINILOK QuickAnchor Plus is preloaded disposable Device Description anchor/inserter assembly designed to facilitate the delivery and installation of the MINILOK QuickAnchor Plus into bone. Indications for Use The MINILOK QuickAnchor Plus is intended for fixation of soft tissue to bone, using suture, for the indications listed below: Ankle: Mid-foot reconstruction Foot: Hallux valgus reconstruction Hand: Ulnar or lateral collateral ligament reconstruction Wrist: Scapholunate ligament reconstruction Safety Biocompatibility studies have demonstrated the MINILOK QuickAnchor Plus to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

Public Health Service

JUN 2 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ruth C. Forstadt Senior Regulatory Affairs Associate Mitek Worldwide 249 Vanderbilt Ave. Norwood, MA 02062

Re: K030995

Trade/Device Name: MINILOK Anchor Plus Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 28, 2003 Received: March 31, 2003

Dear Ms. Forstadt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 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) 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 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 (PMA), 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 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 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 comply with all 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

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Page 2 - Ms. Ruth C. Forstadt

forth in the quality systems (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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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 yours,

R. Mark McMullen

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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### INDICATIONS FOR USE

510(k) Number (if known): K610995

Device Name: MINILOK QuickAnchor Plus

Indications for Use:

MINILOK QuickAnchor Plus is intended for fixation of soft tissue to bone, using suture, for the indications listed below:

Ankle: Mid-foot reconstruction Foot: Hallux Valgus reconstruction Hand: Ulnar or lateral collateral ligament reconstruction Wrist: Scapholunate ligament reconstruction

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
or
Over-the-Counter Use No

/ Mark M
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K030995