TRIDENT ANCHOR

K060914 · Johnson & Johnson Company · HWC · Jun 9, 2006 · Orthopedic

Device Facts

• Record ID: K060914
• Device Name: TRIDENT ANCHOR
• Applicant: Johnson & Johnson Company
• Product Code: HWC · Orthopedic
• Decision Date: Jun 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Trident 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

Trident Anchor is a sterile, metallic bone fixation fastener used for soft tissue-to-bone attachment. Device consists of an anchor pre-mounted on an inserter shaft with an anvil, optionally including a threader tab and #2 sutures. System deployed via reusable Deployment Gun. Used by surgeons in operating room settings for orthopedic repairs including rotator cuff, biceps tenodesis, and ligament reconstructions. Provides secure fixation of soft tissue to bone, facilitating healing and structural stability in orthopedic procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Metallic bone fixation fastener; supplied sterile; pre-mounted on inserter shaft with anvil; includes #2 suture options; deployed via reusable mechanical deployment gun. Class II device under 21 CFR 888.3040.

Indications for Use

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

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

• ROC EZ Fastener (K970089 & K971922)
• Arthrex Pushlock Anchor (K051219)
• ArthroCare Opus Magnum Implant (K042914)

Submission Summary (Full Text)

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K060914 Page 1 of 2

## SECTION 2 – 510(k) SUMMARY

| | Trident Anchor | | JUN - 9 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:<br>508-977-3988<br>Facsimile:<br>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>Trident Anchor | |
| Substantial Equivalence | Trident Anchor is substantially equivalent to:<br>ROC EZ Fastener (K970089 & K971922); the Arthrex Pushlock<br>Anchor (K051219) and the ArthroCare Opus Magnum Implant<br>(K042914). | | |
| Device Classification | This device carries an FDA product code MBI and HWC, and is<br>classified as Fastener, Fixation, Nondegradable, Soft Tissue Smooth or<br>threaded metallic bone fixation fasteners under 21 CFR 888.3040. | | |
| Device Description | The Trident Anchor System includes the Trident Anchor, which will be<br>presented sterile, pre-mounted on an inserter shaft w/anvil with or<br>without a threader tab and suture. The System will be deployed with<br>the use of a reusable Deployment Gun. The Anchor could be provided<br>with a variety of #2 suture options. | | |
| Premarket Notification: Traditional | | | Confidential |

Premarket Notification: Traditional Trident Anchor

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| Indications for Use | Trident Anchor is indicated for use in the following:<br>Shoulder: Rotator Cuff Repair, Biceps Tenodesis<br>Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament<br>Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;<br>Joint Capsule Closure<br>Elbow: Biceps Tendon Reattachment |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and Performance | Results of performance and safety testing have demonstrated that the<br>modified device is substantially equivalent to the predicate devices.<br>Based on the indications for use, technological characteristics, and<br>comparison to predicate devices, the Trident Anchor has been shown to<br>be substantially equivalent to predicate devices under the Federal Food,<br>Drug and Cosmetic Act. |

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Confidential

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 9 2006

DePuy Mitek a Johnson & Johnson Co. % Ms. Ruth C. Forstadt Project Management Lead, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767

Re: K060914

Trade/Device Name: Trident Anchor Regulation Code: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulation Class: II Product Code: HWC, MBI Dated: April 3, 2006 Received: April 4, 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. Iisting 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

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Page 2 -- Ms. Ruth C. Forstadt

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), 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/dsma/dsmamain.html

Sincerely yours,

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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Page Of

510(k) Number (if known): K660914

Device Name: Trident Anchor

Trident Anchor is indicated for use in the following:

Shoulder: Rotor 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

Prescription Use

OR

Over-the -Counter Use No
(Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milliken

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

Number K06 09/4