VERSALOK ANCHOR WITH FREE STRANDS OF ORTHOCORD SUTURE (210808), ETHIBOND SUTURE (210809), AND PANACRYL SUTURE (210810)

K063478 · Depuy Mitek, A Johnson & Johnson Company · HWC · Dec 15, 2006 · Orthopedic

Device Facts

• Record ID: K063478
• Device Name: VERSALOK ANCHOR WITH FREE STRANDS OF ORTHOCORD SUTURE (210808), ETHIBOND SUTURE (210809), AND PANACRYL SUTURE (210810)
• Applicant: Depuy Mitek, A Johnson & Johnson Company
• Product Code: HWC · Orthopedic
• Decision Date: Dec 15, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

VERSALOK Anchor is indicated for use in the following: Shoulder: Rotator Cuff Repair, Biceps Tenodesis Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Joint Capsule Closure Elbow: Biceps Tendon Reattachment

Device Story

Versalok Anchor is a metallic bone fixation fastener used for soft tissue-to-bone attachment. The system consists of the anchor, pre-mounted on an inserter shaft with an anvil, a threader tab, and #2 suture (Orthocord, Panacryl, or Ethibond). The device is deployed using a reusable deployment gun. It is intended for use by surgeons in clinical settings (OR) to secure tendons or ligaments to bone. The anchor provides mechanical fixation, facilitating tissue healing and joint stability. The system is provided sterile.

Clinical Evidence

Bench testing only.

Technological Characteristics

Metallic bone fixation fastener; includes inserter shaft, anvil, and threader tab. Provided sterile. Compatible with various #2 suture types (Orthocord, Panacryl, Ethibond). Mechanical fixation principle. No software or electronic components.

Indications for Use

Indicated for patients requiring soft tissue-to-bone fixation in the shoulder (rotator cuff repair, biceps tenodesis), knee (MCL, LCL, or posterior oblique ligament repair, iliotibial band tenodesis, joint capsule closure), and elbow (biceps tendon reattachment).

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

• Trident Anchor (K060914)

Submission Summary (Full Text)

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# K663478112

# 510(k) SUMMARY

.

### Versalok Anchor

DEC 1 5 2006

:

| Submitter's Name and<br>Address: | DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767 | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Contact Person | Ruth C. Forstadt<br>Project Management Lead, Regulatory Affairs<br>DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767<br>Telephone: [phone]<br>Facsimile: 508-828-3750<br>e-mail: [e-mail]) | |
| Name of Medical Device | Classification Name: | Fastener, Fixation, Nondegradable, Soft<br>Tissue Smooth or threaded metallic bone<br>fixation fasteners |
| | Common/Usual Name:<br>Proprietary Name: | Bone Anchor<br>Versalok Anchor |
| Substantial Equivalence | Versalok Anchor is substantially equivalent to:<br>Trident Anchor (K060914) | |
| Device Classification | The Versalok Anchor device carries an FDA product code MBI and<br>HWC, and is classified as Fastener, Fixation, Nondegradable, Soft<br>Tissue Smooth or threaded metallic bone fixation fasteners under 21<br>CFR 888.3040.<br>Sutures, classified by the FDA, are Class II Medical Devices. The<br>sutures (that are provided with the anchor) are classified as follows:<br>Orthocord suture (a combination of PDS and Polyethylene suture):<br>PDS Suture carries an FDA product code NEW, and is classified as<br>absorbable surgical suture, polydiaxanone under 21 CFR 878.4840.<br>Polyethylene suture carries an FDA product code GAT, and is classified<br>under 21 CFR 878.5000. | |

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Panacryl Suture carries an FDA product code NEW, and is classified as suture, absorbable synthetic polyglycolic acid under 21 CFR 878.4493. Ethibond suture carries an FDA product code of GAS, and is classified as suture, non-absorbable synthetic polyester under 21 CFR 878.5000. The Versalok Anchor System includes the Versalok Anchor, which will Device Description be presented sterile, pre-mounted on an inserter shaft w/anvil with a threader tab and suture. The System will be deployed with the use of a reusable Deployment Gun. The system could be provided with a variety of #2 suture options. The Versalok Anchor is indicated for use in the following: Indications for Use Shoulder: Rotator Cuff Repair, Biceps Tenodesis, Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Joint Capsule Closure Elbow: Biceps Tendon Reattachment Results of performance and safety testing have demonstrated that the Safety and Performance modified device is substantially equivalent to the predicate devices. Based on the indications for use, technological characteristics, and comparison to predicate devices, the Versalok Anchor has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with outstretched wings, rendered in a simple, abstract design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 1 5 2006

DePuy Mitck % Ruth C. Forstadt, RAC Project Management Lead, Regulatory Affairs Raynham, Massachusetts 02767

Re: K063478

Trade/Device Name: Versalok Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulation Class: II Product Code: HWC, MBI, NEW, GAT, GAS, GAM Dated: November 16, 2006 Received: November 17, 2006

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 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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Page 2 - Ruth C. Forstadt, RAC

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 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/industry/support/index.html.

Sincerely vours.

Mark N. Milliken

Mark N. Melkerson 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):

Device Names: Versalok Anchor

VERSALOK Anchor is indicated for use in the following:

Shoulder: Rotator Cuff Repair, Biceps Tenodesis Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Joint Capsule Closure Elbow: Biceps Tendon Reattachment

Mark A. Mellman

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

**510(k) Number** K063478

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Premarket Notification: Special Versalok Anchor

Confidential