FASTIN RC ANCHOR

K041075 · Depuy Mitek, A Johnson & Johnson Company · HWC · Nov 9, 2004 · Orthopedic

Device Facts

• Record ID: K041075
• Device Name: FASTIN RC ANCHOR
• Applicant: Depuy Mitek, A Johnson & Johnson Company
• Product Code: HWC · Orthopedic
• Decision Date: Nov 9, 2004
• 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.

Device Story

Fastin RC Anchor is a threaded titanium alloy (6Al-4V ELI) implantable suture anchor; preloaded on disposable inserter assembly. Used in surgical rotator cuff repair to reattach soft tissue to bone. Surgeon inserts anchor into bone; attached sutures secure soft tissue. Once tissue heals (approx. 6 weeks), anchor remains dormant in bone. Available in 5.0mm and 6.5mm sizes; compatible with Ethibond (non-absorbable), Panacryl (absorbable), and Orthocord (composite) sutures. Device is used in clinical/surgical settings by physicians.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Titanium 6Al-4V ELI (ASTM F-136). Threaded anchor design. Sizes: 5.0mm and 6.5mm. Preloaded on disposable inserter. Suture options: Ethibond, Panacryl, Orthocord. Mechanical fixation device.

Indications for Use

Indicated for rotator cuff repair in the shoulder.

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 RC Anchor (K983818)

Reference Devices

• Orthocord suture (K040004)

Submission Summary (Full Text)

{0}------------------------------------------------

K041075 Pge 192

NOV - 9 2004

## SECTION 9 – 510(k) SUMMARY

| 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 | Device Regulation:<br>Staple, Fixation, Bone<br>(21 CFR 888.3030)<br>Product codes: MBI, HWC, GAM and GAS<br>Common/Usual Name:<br>Staple, Fixation, Bone<br>Proprietary Name:<br>Fastin RC Anchor |
| Device Classification | Non-Absorbable Metal Suture Anchors carry FDA product codes MBI,<br>HWC, GAM & GAS, and are classified as Staple, Fixation, Bone under<br>21 CFR 888.3030. |
| Indications for Use | The Fastin RC Anchor is intended for:<br>Shoulder: Rotator cuff repair. |
| Device Description | The Mitek 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 designed<br>to be used in the surgical repair of the rotator cuff, and are made from<br>Titanium 6Al-4V ELI per ASTM F-136. The attached suture is then<br>used to reattach soft tissue back to bone where it reconnects through the<br>healing process. Once the tissue has healed (about six weeks) the<br>anchor function is complete and the implant becomes dormant in the |

{1}------------------------------------------------

page of

bone. The proposed Fastin RC Anchor is available in 5.0mm and 6.5mm sizes and is offered with three suture options, non-absorbable Ethibond, absorbable Panacryl, and composite Orthocord.

| Substantial Equivalence | The changes being made from the predicate Fastin RC Anchor to the<br>proposed Fastin RC Anchor are either dimensional or a material<br>change. The dimensional change is minor (as described in detail in<br>Section 2 - Device Description) and does not affect the safety or<br>effectiveness of the device. The second change is a material change to<br>include a third suture option, composite Orthocord (K040004).<br>Orthocord suture was previously cleared by FDA for use in general soft<br>tissue approximation and/or ligation, including use in orthopedic<br>surgeries. The addition of Orthocord suture option and the dimensional<br>change made to the design of the anchor does not alter the intended use,<br>safety and effectiveness or the fundamental scientific technology of the<br>predicate devices.<br>Mitek believes that the Fastin RC Anchor is substantially equivalent to<br>Mitek's existing Fastin RC Anchor (K983818).<br>A statement of substantial equivalence is provided in Section 3 and the<br>510(k) "Substantial Equivalence" Decision-Making Process is attached<br>in Appendix III. |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and Performance | The determination of substantial equivalence for this device was based<br>on a detailed device description and changes that intend to be made to<br>currently marketed devices. Non-clinical laboratory testing was<br>performed demonstrating that the device is safe and performs as<br>intended. |

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

NOV - 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ruth C. Forstadt Project Management Lead, Regulatory Affairs Depuy Mitek A Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062

Re: K041075

Trade/Device Name: Fastin RC Anchors Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HWC, MAI Dated: August 13, 2004 Received: August 16, 2004

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.

{3}------------------------------------------------

Page 2 -- Ms. Ruth C. Forstadt

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 vours.

Sincerely yours,

L. Mark A. Millican

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

{4}------------------------------------------------

Page _ 1 of 1

510(k) Number (if known): K041075

Device Name: Fastin RC Anchors

The Fastin RC Anchors are intended for: Shoulder: Rotator cuff repair.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-Counter Use

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

Premarket Notification: Traditional
Fastin RC Anchors
510(k) Number K041075
Confidential v