SUPER QUICKANCHOR PLUS

K041116 · Depuy Mitek · JDR · May 28, 2004 · Orthopedic

Device Facts

• Record ID: K041116
• Device Name: SUPER QUICKANCHOR PLUS
• Applicant: Depuy Mitek
• Product Code: JDR · Orthopedic
• Decision Date: May 28, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mitek Super QUICKANCHOR Anchor Plus is intended for fixation of USP size #2 through #5 suture to bone for the indications listed below. Shoulder: Rotator cuff repair; capsular repair; biceps repair; deltoid repair. Ankle: Achilles tendon repair/reconstruction. Knee: Extra capsular repairs; Reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.

Device Story

Metallic bone anchor system used for reattaching soft tissue to bone. Input: manual force applied by surgeon via inserter shaft. Transformation: anchor deployment into bone to secure suture. Output: fixed suture anchor. Used in surgical settings (OR) by orthopedic surgeons. Features enhanced ergonomics for single-handed operation and increased inserter shaft length for improved visualization. Benefits patient by providing secure fixation for tendon and ligament repairs.

Clinical Evidence

No clinical data. Biocompatibility studies demonstrated the device to be non-toxic, non-irritating, and non-cytotoxic.

Technological Characteristics

Metallic anchor composed of 6Al-4V ELI Titanium base and NiTi Titanium Alloy arcs. Used for bone fixation. Features include ergonomic inserter handle and extended shaft length. Sterilization method not specified.

Indications for Use

Indicated for soft tissue-to-bone fixation in shoulder (rotator cuff, capsular, biceps, deltoid repairs), ankle (Achilles tendon repair/reconstruction), and knee (extra capsular repairs, ligament reattachments, ITB tenodesis, patellar ligament/tendon avulsions) procedures using USP size #2 through #5 suture.

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

• Mitek SuperAnchor QuickAnchor (K930893)

Submission Summary (Full Text)

{0}------------------------------------------------

K04 1116

Pg 1 of 2

## MAY 2 8 2004

## 510(k) Summary – Super QuickAnchor Plus

| Submitter's Name and<br>Address: | DePuy Mitek<br>a Johnson & Johnson company<br>249 Vanderbilt Avenue<br>Norwood, MA 02062 |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Allyson Barford<br>Regulatory Affairs Associate<br>DePuy Mitek<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 | Device Regulation:<br>Staple, Fixation, Bone<br>(21 CFR 888.3030)<br>Product code: MBI<br>Common/Usual Name:<br>Staple, Fixation, Bone<br>Proprietary Name:<br>Super QuickAnchor Plus |
| Device Classification | Staple, Fixation, Bone devices have been classified as Class II, MBI<br>according to 21 CFR 888.3030. No performance standards have been<br>established under Section 514 of the Food, Drug and Cosmetic Act for<br>Staple, Fixation, Bone devices. |
| Indications for Use | The Mitek Super QUICKANCHOR Anchor Plus is intended for<br>fixation of USP size #2 through #5 suture to bone for the indications<br>listed below.<br>Shoulder: Rotator cuff repair; capsular repair; biceps repair; deltoid<br>repair.<br>Ankle: Achilles tendon repair/reconstruction. |
| | Knee: Extra capsular repairs; Reattachment of: medial collateral<br>ligament, lateral collateral ligament, posterior oblique ligament or joint |
| Special 510(k) Premarket Notification: Super QuickAnchor Plus | CONFIDENTIAL |

DePuy Mitek

{1}------------------------------------------------

pg. 2 of 2.

capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.

| Device Description | The Super Quick Anchor Plus is intended as an upgrade of the current Super QuickAnchor. The new system includes enhanced ergonomics, and improved visualization. The product will be offered with both Ethibond and Panacryl suture. The ergonomics are improved by allowing a single-handed operation. In addition, the visualization of the anchor is improved by increasing the length of the inserter shafts. The Super QuickAnchor is a metallic (6Al-4V ELI Titanium base and NiTi Titanium Alloy arcs) anchor and is used to assist in the reattachment of soft tissue to bone. The anchor is identical to the currently marketed Mitek SuperAnchor QuickAnchor (K930893). |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence | Based on the type of changes being made and the fact that the Super QuickAnchor Plus represents the same fundamental scientific technology as the existing SuperAnchor QuickAnchor; Mitek believe that Super QuickAnchor Plus is substantially equivalent to Mitek's existing SuperAnchor QuickAnchor (K980893). |
| Safety | Biocompatibility studies have demonstrated the Super Anchor QuickAnchor Plus to be non-toxic, non-irritating, and non-cytotoxic. |

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures.

Public Health Service

MAY 2 8 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Allyson Barford Regulatory Affairs Associate Depuy Mitek a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062

Re: K041116 Trade/Device Name: Super Quick Anchor Plus Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDR Dated: April 5, 2004 Received: April 29, 2004

Dear Ms. Barford:

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 markcted 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 cither 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 I·DA 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 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.

{3}------------------------------------------------

## Page 2 - Allyson Barford

This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter with a a not of your finding of substantial equivalence of your device to a legally promated prodicate 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 rryou decire 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 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,

Mark A Milkman

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

{4}------------------------------------------------

## INDICATIONS FOR USE

510(k) Number (if known):

Device Names:

Super QuickAnchor Plus

Indications for Use:

The Mitek Super QUICKANCHOR Anchor Plus is intended for fixation of USP size #2 through #5 suture to bone for the indications listed below.

Shoulder: Rotator cuff repair; capsular repair; biceps repair; deltoid repair.

KO4 1116

Ankle: Achilles tendon repair/reconstruction.

Knee: Extra capsular repairs; Reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendor avulsions.

Mark N Milkers
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

**510(k) Number** K041116

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OT

Over-the-Counter Use

Special 510(k) Premarket Notification: Super QuickAnchor Plus DePuy Mitek

CONFIDENTIAL