PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732

K041117 · Depuy Mitek · JDR · May 28, 2004 · Orthopedic

Device Facts

• Record ID: K041117
• Device Name: PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732
• 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 Panalok RC QuickAnchor Plus and Dual Suture Panalok RC QuickAnchor Plus Anchors are intended for fixation of USP size #2 suture to bone for the indication listed below. Shoulder: Rotator cuff repair.

Device Story

The Panalok RC QuickAnchor Plus and Dual Suture Panalok RC QuickAnchor Plus are preloaded, disposable anchor/inserter assembly systems. The device consists of a one-piece absorbable suture anchor made of molded Poly(L-lactide) polymer. It is designed to facilitate the fixation of USP size #2 suture to bone during rotator cuff repair procedures. The Dual Suture version features a dimensional modification to the anchor to accommodate two strands of suture instead of one. The device is used by surgeons in a clinical setting to secure soft tissue to bone. By providing a stable anchor point for sutures, the device assists in the reattachment of the rotator cuff, potentially improving healing and functional outcomes for the patient.

Clinical Evidence

No clinical data provided. Biocompatibility studies were conducted to demonstrate the devices are non-toxic, non-irritating, and non-cytotoxic.

Technological Characteristics

One-piece suture anchor constructed of molded Poly(L-lactide) polymer. Preloaded disposable anchor/inserter assembly system. Designed for fixation of USP size #2 suture to bone. No software or electronic components.

Indications for Use

Indicated for rotator cuff repair in the shoulder, specifically for the fixation of USP size #2 suture to bone.

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 Absorbable Toggle Anchor (K964013)

Submission Summary (Full Text)

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MAY 2 8 2004

pg 1 of 2 K041117

## 510(k) Summary – Panalok RC QuickAnchor Plus and Dual Suture Panalok RC 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:<br>Facsimile:<br>e-mail: | 781-251-2794<br>781-278-9578<br>[e-mail] | |
| Name of Medical Device | Classification Name: | Screw, Fixation, Bone Staple | |
| | Common/Usual Name: | Appliance for reconstruction of bone to<br>soft tissue | |
| | Proprietary Name: | Panalok RC QuickAnchor Plus<br>Dual Suture Panalok RC QuickAnchor Plus | |
| Device Classification | Screw, Fixation, Bone Staple devices have been classified as Class II<br>GAM and MAI according to 21 CFR 888.3030. No performance<br>standards have been established under Section 514 of the Food, Drug<br>and Cosmetic Act for Screw, Fixation, Bone Staple devices. | | |
| Indications for Use | The Mitek Panalok RC QuickAnchor Plus and Dual Suture Panalok<br>RC QuickAnchor Plus Anchors are intended for fixation of USP size<br>#2 suture to bone for the indication listed below.<br>Shoulder: Rotator cuff repair. | | |
| Device Description | The PANALOK RC QuickAnchor Plus is a preloaded disposable<br>anchor/inserter assembly system designed to facilitate the fixation of<br>USP size #2 suture to bone. The absorbable polylactic acid (PLA)<br>anchor is the identical anchor as that of the Mitek Toggle Anchor, and<br>the sutures are similar to those used in the Mitek Toggle Anchor | | |
| Special 510(k) Premarket Notification: Panalok RC QuickAnchor Plus and<br>Dual Suture Panalok RC QuickAnchor Plus | | CONFIDENTIAL | |

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pg 2 of 2

System and other Mitek Anchor systems. The Panacryl and Ethibond sutures are manufactured by Ethicon, Inc. The absorbable anchor is a one-piece suture anchor constructed of molded Poly(1 - lactide) polymer.

The Dual Suture PANALOK RC QuickAnchor Plus is preloaded disposable anchor/inserter assembly system designed to facilitate the fixation of USP size #2 suture to bone. The absorbable polylactic acid (PI.A) anchor is similar to the Mitek Toggle Anchor; the only change is a dimensional change to accommodate two strands of suture instead of onc. The sutures are similar to those used in the Mitck Toggle Anchor System and other Mitek Anchor systems. The Panacryl and Ethibond sutures are manufactured by Ethicon, Inc. The absorbable anchor is a one-piece suture anchor constructed of molded Poly(Llactide) polymer.

Substantial Equivalence Based on the degree of changes being made to the original Mitek Absorbable Toggle Anchor (K964013) and the fact that the Panalok RC QuickAnchor Plus and Dual Suture Panalok RC QuickAnchor Plus represent the same fundamental scientific technology as the original Mitek Absorbable Toggle Anchor; Mitek believes that the Panalok RC QuickAnchor Plus and Dual Suture Panalok RC Ouick Anchor Plus are substantially equivalent to the Mitek Absorbable Toggle Anchor manufactured by DePuy Mitek.

:

Biocompatibility studies have demonstrated the Panalok RC Safety QuickAnchor Plus and Dual Suture Panalok RC QuickAnchor Plus Anchors to be non-toxic, non-irritating, and non-cytotoxic.

CONFIDENTIAL

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 8 2004

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

Rc: K041117 Trade/Device Name: Panalok RC QuickAnchor Plus Dual Suture Panalok RC QuickAnchor 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 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 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 FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other l'ederal 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and wyour he FDA finding of substantial equivalence of your device to a legally marketed predicated 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 If you desire specific acries in 301) 594-4659. 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 other gollord 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,

Sincerely, John,

L. 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): K041117

Device Names:

Panalok RC QuickAnchor Plus Dual Suture Panalok RC Quick Anchor Plus

Indications for Use:

The Panalok RC QuickAnchor Plus and Dual Suture Panalok RC QuickAnchor Plus are intended for fixation of USP size #2 suture to bone for the indication listed below. Shoulder: Rotator cuff repair.

Mark N Milhason

and Neurological Devices

510(k) Number K041117

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use _

or

Over-the-Counter Use_

Special 510(k) Premarket Notification: Panalok RC QuickAnchor Plus and Dual Suture Panalok RC QuickAnchor Plus DePuy Mitek

CONFIDENTIAL