SPIRALOK ANCHOR

K041069 · Depuy Mitek, A Johnson & Johnson Company · HWC · Nov 9, 2004 · Orthopedic

Device Facts

• Record ID: K041069
• Device Name: SPIRALOK 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 Spiralok Anchor is intended for: Shoulder: Rotator cuff repair.

Device Story

Spiralok Anchor is a PLA threaded suture anchor preloaded on a disposable inserter assembly; used for fixation of two strands of suture to bone. Device facilitates reattachment of soft tissue to bone to support healing. Used in orthopedic surgery; operated by surgeons. Input is bone/tissue site; output is mechanical fixation of suture to bone. Includes options for Ethibond non-absorbable, Panacryl absorbable, or Orthocord composite sutures, potentially with tapered needles for tissue passage.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical laboratory testing and device description.

Technological Characteristics

PLA threaded suture anchor; preloaded on disposable inserter. Includes suture options: Ethibond (non-absorbable), Panacryl (absorbable), and Orthocord (composite).

Indications for Use

Indicated for patients requiring 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

• BioFastin RC Anchor (K021883)

Reference Devices

• Orthocord composite suture (K040004)

Submission Summary (Full Text)

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K041069 page '1 of 2

NOV - 9 2004

## SECTION 9 -- 510(k) SUMMARY

| 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>781-251-2794<br>Facsimile:<br>781-278-9578<br>e-mail:<br>[e-mail] |
| Name of Medical Device | Device Regulation:<br>Fastener, Fixation, Biodegradable, Soft Tissue<br>(21 CFR 888.3030)<br>Product code: 87 MAI<br>Common/Usual Name:<br>Biodegradable Fixation Fastener<br>Proprietary Name:<br>Spiralok Anchor |
| Device Classification | Suture Anchors are classified by the FDA as Class II Medical Devices.<br>Absorbable PLA Suture Anchors carry a FDA product code 87 MAI,<br>and are classified as Fastener, Fixation, Biodegradable, Soft Tissue<br>under 21 CFR 888.3030. |
| Indications for Use | The Spiralok Anchor is intended for:<br>Shoulder: Rotator cuff repair. |
| Device Description | The SpiraLok Anchor, like the current BioFastin RC Anchor, is a PLA<br>threaded suture anchor preloaded on a disposable inserter assembly<br>intended for fixation of two strands of suture to bone. Ethibond non-<br>absorbable suture, the Panacryl absorbable suture and the Orthocord<br>composite suture options may include tapered needles to facilitate<br>suture passage through tissue. The attached suture is then used to<br>reattach soft tissue back to bone where it reconnects through the healing |

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## process. The changes being made from the predicate BioFastin RC Anchor to Substantial Equivalence the proposed Spiralok Anchor are either dimensional or material changes. The dimensional changes are minor (as described in detail in Section 2 - Device Description) and do not affect the safety or effectiveness of the device. The second change is a material change to include a third suture option, composite Orthocord (K040004). Orthocord suture was previously cleared by FDA for use in general soft tissue approximation and/or ligation, including use in orthopedic surgeries. The addition of Orthocord suture option and the dimensional changes made to the design of the anchors do not alter the intended use. safety and effectiveness or the fundamental scientific technology of the predicate device. Mitek believes that the Spiralok Anchor is substantially equivalent to Mitek's BioFastin RC Anchor (K021883). A statement of substantial equivalence is provided in Section 3 and the 510(k) "Substantial Equivalence" Decision-Making Process is attached in Appendix III. Safety and Performance The determination of substantial equivalence for this device was based on a detailed device description and changes that intend to be made to currently marketed devices. Non-clinical laboratory testing was performed demonstrating that the device is safe and performs as intended.

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Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the edge. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 2004

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

Re: K041069

Trade/Device Name: Spiralok Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: 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.

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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 yours,

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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Page _ of of

510(k) Number (if known): K041069

Device Name: Spiralok Anchor

The Spiralok Anchor is 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 Y A (Per 21 CFF 801.109)

Over-the _Counter Use OR

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

Premarket Notification: Traditional Spiralok Anchors

510(k) Number

Confidential vi