ARTHREX FIBERWIRE

K071622 · Arthrex, Inc. · GAT · Jul 3, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K071622
• Device Name: ARTHREX FIBERWIRE
• Applicant: Arthrex, Inc.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Jul 3, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex FiberWire® suture configurations are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.

Device Story

Arthrex FiberWire® consists of non-absorbable synthetic suture configurations; includes single strands with/without needles, stiffened ends, suture chains, and FiberTape®. Used by surgeons in clinical settings for soft tissue approximation and ligation; may be incorporated into surgical constructs involving allograft or autograft tissues. Device provides mechanical fixation for tissue repair; benefits patient by maintaining structural integrity of surgical site during healing process.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use similarity to predicate devices.

Technological Characteristics

Non-absorbable synthetic suture (polyethylene). Configurations include single strand, needles, stiffened ends, suture chains, and tape. Class II device per 21 CFR 878.5010.

Indications for Use

Indicated for soft tissue approximation and ligation in patients requiring surgical repair, including procedures involving allograft or autograft tissue constructs.

Regulatory Classification

Identification

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• FiberWire® (K041589)
• FiberWire® Suture Grafting Kit (K041553)

Submission Summary (Full Text)

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## JUL - 3 2007

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## 4 510(k) Summary of Safety and Effectiveness

| Manufacturer/Sponsor | Arthrex, Inc.1370 Creekside Boulevard Naples, Florida 34108-1945 |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact | Ann Waterhouse, RAC |
| | Regulatory Affairs Project Manager |
| | Telephone: [phone], ext. 1179 |
| | Fax: [phone] |
| | Email: [e-mail] |
| Trade Name | Arthrex FiberWire® |
| Common Name | Suture, non-absorbable |
| Product Code -<br>Classification Name | GAT, Suture, Non-absorbable, Synthetic, Polyethylene: 21 CFR 878.5000<br>GAP, Suture Non-absorbable, Silk: 21 CFR 878.5030 |
| Predicate Device | K041589, FiberWire® |
| | K041553, FiberWire® Suture Grafting Kit |
| Device Description<br>and Intended Use | Arthrex FiberWire® configurations consist of single strand suture with or<br>without needles, suture with stiffened ends, suture chains, and FiberTape®. |
| | The Arthrex FiberWire® suture configurations are intended for use in soft<br>tissue approximation and or ligation. These sutures may be incorporated,<br>as components, into surgeries where constructs including those with<br>allograft or autograft tissues are used for repair. |
| Substantial<br>Equivalence Summary | The Arthrex FiberWire® is substantially equivalent to the predicate Arthrex<br>FiberWire® in which the basic features and intended uses are the same.<br>Any differences between the FiberWire and the predicate<br>K041589/K041553 are considered minor and do not raise questions<br>conceming safety and effectiveness. Based on the information submitted,<br>Arthrex, Inc. has determined that the new FiberWire® is substantially<br>equivalent to the currently marketed predicate device. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 3 2007

Arthrex, Inc. % Ms. Ann Waterhouse, RAC Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K071622

Trade/Device Name: Arthrex FiberWire® Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAT Dated: June 13, 2007 Received: June 19, 2007

Dear Ms. Waterhouse:

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. Ann Waterhouse, 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 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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3 Indications for Use Form

Indications for Use

| 510(k) Number: | K071622 |
|----------------|--------------------|
| Device Name: | Arthrex FiberWire® |

The Arthrex FiberWire® suture configurations are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.

Prescription Use _X_AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ØDE)

CDRH, Office of Device Evaluation (ODE)

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