PANALOK RC LOOP ANCHOR

K041065 · Depuy Mitek · JDR · May 7, 2004 · Orthopedic

Device Facts

• Record ID: K041065
• Device Name: PANALOK RC LOOP ANCHOR
• Applicant: Depuy Mitek
• Product Code: JDR · Orthopedic
• Decision Date: May 7, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mitek Panalok RC Loop Anchor is indicated for use in soft tissue to bone fixation in association with adequate post-operative immobilization as follows: Shoulder: Rotator cuff repair.

Device Story

Panalok RC Loop Anchor is a preloaded, absorbable, disposable suture anchor/inserter assembly. Used for soft tissue-to-bone fixation during rotator cuff repair. Constructed from molded Poly(L-lactide) polymer. Designed to facilitate soft tissue repair to bone with enhanced suture-sliding capabilities. Operated by surgeons in a clinical/surgical setting. Device provides mechanical fixation of soft tissue to bone; benefits patient by securing tissue during healing process.

Clinical Evidence

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

Technological Characteristics

Absorbable suture anchor constructed of molded Poly(L-lactide) polymer. Disposable, preloaded anchor/inserter assembly. Mechanical fixation principle.

Indications for Use

Indicated for soft tissue to bone fixation in the shoulder for rotator cuff repair, requiring post-operative immobilization.

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

• BioKnotless Anchor (K002639)
• Panalok RC Anchor (K964013)

Submission Summary (Full Text)

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K041065 PG142

## MAY - 7 2004

## 510(k) Summary - Panalok RC Loop Anchor

| Submitter's Name and 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 | Classification Name: Screw, Fixation, Bone Staple<br>Common/Usual Name: Appliance for reconstruction of bone to soft tissue<br>Proprietary Name: Panalok RC Loop Anchor |
| Device Classification | Screw, Fixation, Bone Staple devices have been classified as Class II, GAM and MAI according to 21 CFR 888.3030. No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for Screw, Fixation, Bone Staple devices. |
| Indications for Use | The Mitek Panalok RC Loop Anchor is indicated for use in soft tissue to bone fixation in association with adequate post-operative immobilization as follows:<br>Shoulder: Rotator cuff repair. |
| Device Description | The Panalok RC Loop Anchor System is a preloaded absorbable disposable suture anchor/inserter assembly designed to allow soft tissue repair to bone with enhanced suture-sliding capabilities. The absorbable anchor is a one-piece suture anchor constructed of molded Poly(L-lactide) polymer. |

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KACH065 pgehy?

| Substantial Equivalence | Based on the type of changes being made and the fact that the Panalok RC Loop Anchor represents the same fundamental scientific technology as the existing S BioKnotless Anchor (K002639) and Panalok RC Anchor (K964013); Mitek believes the Panalok RC Loop Anchor is substantially equivalent to the BioKnotless Anchor (K002639) and Panalok RC Anchor (K964013) manufactured by DePuy Mitek. |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety | Biocompatibility studies have demonstrated the Panalok RC Loop |

Anchor to be non-toxic, non-irritating, and non-cytotoxic.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 7 2004

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

Re: K041065

Trade/Device Name: Panalok RC Loop Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDR and MAI Dated: April 5, 2004 Received: April 23, 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 marketed in interstate commercc 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Allyson Barford

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,

Mark A. Millman

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): K041065

Device Names:

Panalok RC Loop Anchor

Indications for Use:

The Mitek Panalok RC Loop Anchors arc indicated for use in soft tissue to bone fixation in association with adequate post-operative immobilization as follows: Shoulder: Rotator cuff repair.

O. Mark N. Mellam

Division of General, Restorative, and Neurological Devices

510(k) Number K041065

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

Concurrence of CDRH, Office of Device Evaluation (ODF.)

Prescription Use

OL

Over-the-Counter Use Uh

Special 510(k) Premarket Notification: Panalok RC Loop Anchors DePuy Mitck

CONFIDENTIAL