FASTIN RC ANCHOR

K060664 · Depuy Mitek · HWC · Jun 6, 2006 · Orthopedic

Device Facts

• Record ID: K060664
• Device Name: FASTIN RC ANCHOR
• Applicant: Depuy Mitek
• Product Code: HWC · Orthopedic
• Decision Date: Jun 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FASTIN RC Anchor is intended for: Shoulder: Rotator Cuff Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair and SLAP Repair; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Tennis Elbow, Ulnar or Radial Collateral Ligament Reconstruction.

Device Story

Threaded titanium alloy implantable suture anchor; preloaded on disposable inserter assembly; used for fixation of two suture strands; enables reattachment of soft tissue to bone; facilitates healing process; implant becomes dormant post-healing; used in surgical settings by orthopedic surgeons; provides mechanical fixation to support tissue repair; benefits patient by restoring structural integrity of tendons/ligaments.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Material: Titanium 6Al-4V ELI per ASTM F-136. Design: Threaded suture anchor. Sizes: 5.0mm and 6.5mm. Suture options: Ethibond (non-absorbable), Panacryl (absorbable), Orthocord (composite). Delivery: Preloaded on disposable inserter assembly.

Indications for Use

Indicated for patients requiring soft tissue-to-bone fixation in shoulder (rotator cuff, SLAP, biceps, AC joint), foot/ankle (lateral/medial stabilization, Achilles), knee (MCL, LCL, patellar tendon, posterior oblique, IT band), and elbow (biceps, tennis elbow, collateral ligament) 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

• FASTIN Anchor (K945203)
• Arthrex Titanium Corkscrew Anchor (K003816)

Submission Summary (Full Text)

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K60664 page 1 of 2

JUN -6 2006

## SECTION 6 -- 510(k) SUMMARY

Page 1 of 2

| Submitter's Name and<br>Address: | DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive,<br>Raynham, MA 02767 USA |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ruth Forstadt, RAC<br>Project Management Lead, Regulatory Affairs<br>DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive,<br>Raynham, MA 02767 USA<br>Telephone: [phone]<br>Facsimile: [phone]<br>e-mail: [e-mail] |
| Name of Medical Device | Device Regulation:<br>Fastener, Fixation, Non-Degradable, Soft Tissue<br>(21 CFR 888.3040)<br>Product code: 87 MBI<br>Common/Usual Name:<br>Proprietary Name:<br>FASTIN RC Anchor |
| Device Classification | In accordance with per 21 CFR 888.3040, suture anchors are classified<br>by the FDA as Class II Medical Devices. |
| Indications for Use | The FASTIN RC Anchor is intended for: Shoulder: Rotator Cuff<br>Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair and<br>SLAP Repair; Foot/Ankle: Lateral Stabilization, Medial Stabilization,<br>Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair,<br>Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior<br>Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Biceps<br>Tendon Reattachment, Tennis Elbow, Ulnar or Radial Collateral<br>Ligament Reconstruction. |
| Device Description | The FASTIN RC Anchor is a threaded titanium alloy<br>implantable suture anchor preloaded on a disposable inserter assembly<br>intended for fixation of two strands of suture. The anchors are made<br>from Titanium 6A1-4V ELI per ASTM F- 136. The attached suture is<br>then used to reattach soft tissue back to bone where it reconnects<br>through the healing process. Once the tissue has healed (about six.<br>weeks) the anchor function is complete and the implant becomes<br>dormant in the<br>The FASTIN RC Anchor is available in 5.0mm and<br>6.5mm sizes and is offered with three suture options, non-absorbable<br>Ethibond, absorbable Panacryl, and composite Orthocord. |
| Substantial Equivalence | The FASTIN RC Anchor is a commercially marketed device that was<br>originally subject of K983818 (cleared November 23, 1998). When<br>used for the proposed indications the device is substantially equivalent<br>to the FASTIN Anchor (K945203) and the Arthrex Titanium Corkscrew<br>Anchor (K003816). |
| Safety and Performance | The determination of substantial equivalence for this device was based<br>on a detailed device description. Non-clinical laboratory testing was<br>performed demonstrating that the device is safe and can be considered<br>substantially equivalent to the predicate FASTIN Anchor for the<br>proposed new intended uses. |

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## 510(k) SUMMARY

## Page 2 of 2

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized representation of three human figures connected at the shoulders.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 2006

DePuy Mitek a Johnson & Johnson Company c/o Ms. Ruth Forstadt, RAC Project Management Lead, Regulatory Affairs 325 Paramount Drive, Raynham, Massachusetts 02767

Re: K060664

Trade/Device Name: Fastin RC Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI Dated: May 3, 2006 Received: May 5, 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

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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.

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 (240) 276- 0120. 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 yours,

Hubert Lenfercus

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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510(k) Number (if known): _ Ko6o664

Device Name: FASTIN RC Anchor

The FASTIN RC Anchors are indicated for the following:

- Shoulder: Rotator Cuff Repair, SLAP Repair, Biceps Tenodesis, Acromio-. Clavicular Separation Repair and SLAP Repair
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair .
- Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, . Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
- Elbow: Biceps Tendon Reattachment, Tennis Elbow, Ulnar or Radial Collateral . Ligament Reconstruction.

Prescription Use

OR

Over-the -Counter Use K (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)

Hulut Turner

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

**510(k) Number** K060664