CUFFLOK ANCHOR

K031519 · Mitek Worldwide · MAI · Jun 6, 2003 · Orthopedic

Device Facts

• Record ID: K031519
• Device Name: CUFFLOK ANCHOR
• Applicant: Mitek Worldwide
• Product Code: MAI · Orthopedic
• Decision Date: Jun 6, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The CUFFLOK Anchor is indicated for shoulder rotator cuff repair.

Device Story

CUFFLOK Anchor is a three-part, partially bioabsorbable polymer implant used for shoulder rotator cuff repair to secure soft tissue to bone. The device consists of a tapered tip (PLA with blue dye #6), a sleeve (polypropylene blue), and an inner suture pin (PLA with blue dye #6). It is supplied with ETHIBOND non-absorbable sutures and a stainless steel needle. The implant is mounted on a stainless steel trocar and deployed using a Delivery Gun. The device is intended for use by surgeons in a clinical setting. Biocompatibility testing confirms the device is non-toxic, non-irritating, non-sensitizing, and non-cytotoxic.

Clinical Evidence

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

Technological Characteristics

Partially bioabsorbable three-part polymer implant. Materials: PLA (tapered tip and inner suture pin) and polypropylene (sleeve). Includes ETHIBOND non-absorbable sutures and stainless steel needle. Delivery system: stainless steel trocar and Delivery Gun. Mechanical fixation principle.

Indications for Use

Indicated for shoulder rotator cuff repair in patients requiring soft tissue to bone fixation.

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

• CUTTACK Anchor (K003076)

Submission Summary (Full Text)

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JUN - 6 2003

# SECTION 2 - 510(k) SUMMARY

### CUFFLOK Anchor

| Submitter's Name and Address: | Mitek Worldwide a division of ETHICON Inc. a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, MA 02062 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ruth C. Forstadt Senior Regulatory Affairs Associate Mitek Worldwide a division of ETHICON Inc. a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, MA 02062 |
| Telephone: | 781-251-3188 |
| Facsimile: | 781-278-9578 |
| e-mail: | [e-mail] |
| Name of Medical Device | |
| Classification Name: | Fastener, Fixation, Biodegradable, Soft Tissue |
| Common/Usual Name: | Bone Anchor |
| Proprietary Name: | CUFFLOK Anchor |
| Substantial Equivalence | CUFFLOK Anchor is substantially equivalent to: CUTTACK Anchor (K003076) manufactured by Mitek Worldwide, a division of Ethicon, Inc., a Johnson & Johnson Company, 249 Vanderbilt Avenue, Norwood, MA 02062. |
| Device Classification | Bone anchors/screws are classified by FDA as a Class II Medical Devices under the generic category of Single/Multiple Component Metallic Bone Fixation Appliances, Orthopedic Devices Panel (reference 21 CFR §888.3030). Product code MAI. |
| Device Description | The CUFFLOK Anchor is a partially bioabsorbable three-part polymer implant designed for use in shoulder rotator cuff repair and is used to secure soft tissue to bone. The three components of the implant are a |

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tapered tip (PLA with blue dye #6), a sleeve (polypropylene blue) and an inner suture pin (PLA with blue dye #6). The anchor is also provided with ETHIBOND non-absorbable sutures and a stainless steel needle.

Similar to the currently marketed CUFFTACK Anchor, the implant is mounted on a stainless steel trocar and placement of the implant is facilitated via use of a Delivery Gun.

The CUFFLOK Anchor is indicated for shoulder rotator cuff repair. Indications for Use の 2007年 10月 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時

Safety

Biocompatibility studies have demonstrated the CUFFLOK Anchor to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic.

#### CONFIDENTIAL

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

JUN - 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ruth C. Forstadt Senior Regulatory Affairs Associate Mitek Worldwide A division of ETHICON Incorporated A Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062

K031519 Re:

> Trade Name: CUFFLOK Anchor Regulation Number: 21 CFR 888.3030, 21 CFR 878.5000 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II

Product Code: MAI, GAT Dated: May 14, 2003 Received: May 19, 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.

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Page 2 - Ms. Ruth C. Forstadt

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 forth in the quality systems (OS) 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 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 your device, please 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 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.

Miriam C. Provost

for 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): K 43 3 15 19

Device Name: CUFFLOK Anchor

Indications for Use:

The CUFFLOK Anchor is indicated for shoulder rotator cuff repair.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

or

Over-the-Counter Use -------

:

Muriam C. Provost

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

510(k) Number K03/5/9

CONFIDENTIAL