MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE

K033718 · Arthrotek, Inc. · GAT · Feb 12, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K033718
• Device Name: MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE
• Applicant: Arthrotek, Inc.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Feb 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MaxBraid™ Polyethylene Plus and Polyester Plus suture is indicated for general soft tissue approximation and/or ligation

Device Story

MaxBraid™ sutures are nonabsorbable, synthetic surgical sutures used for soft tissue approximation and ligation. Two configurations: Polyester Plus (polyester core, braided polyethylene/polyester outer layer) and Polyethylene Plus (polyethylene core, braided polyethylene/polyester outer layer). Both are size 2 USP, 38 inches long, silicone-coated for tissue passage, and available with or without needles. Used by surgeons in clinical settings; may be used with commercially available suture anchors. Provides mechanical tissue support during healing.

Clinical Evidence

No clinical data provided. Bench testing demonstrated compliance with USP 24 standards for nonabsorbable sutures.

Technological Characteristics

Nonabsorbable synthetic suture; materials include polyester and polyethylene; silicone coating. Size 2 USP. Supplied with or without needles. Sterilization method not specified. No software or electronic components.

Indications for Use

Indicated for general soft tissue approximation and/or ligation in patients requiring surgical suture.

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

• Arthrex FiberWIRE™ (K010673)
• Polyester Nonabsorbable Surgical Suture (K001172)

Submission Summary (Full Text)

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FEB 1 2 2004

K033718
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Image /page/0/Picture/2 description: The image shows the logo for ARTHROTEK, a Biomet Company. The logo is in black and white, with the word "ARTHROTEK" in large, bold letters. The "O" in ARTHROTEK is a solid black circle. Below the word "ARTHROTEK" is the phrase "A Biomet Company" in smaller letters.

CORPORATE HEADOL ARTERS

## 510(k) Summary

Applicant/Sponsor: Arthrotek, Inc.

Patricia Sandborn Beres Contact Person: Senior Requiatory Specialist Biomet Manufacturing Corp.

Proprietary Name: MaxBraid™ Polvester Plus and Polyethylene Plus Suture

Classification Name: Suture, nonabsorbable, synthetic, polyethylene (21 CFR 878.500)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Arthrex FiberWIRE™ -K010673 (Arthrex, Inc.) and Polyester Nonabsorbable Surgical Suture - K001172 (CP Medical)

Device Description: Two configurations of MaxBraid™ suture are included in this submission. The first consists of a polyester core with a braided polyethylene and polyester outer layer with the trade name of MaxBraid™ Polyester Plus Suture. The second type consists of a polyethylene core with a braided polyethylene and polyester outer layer with the trade name of MaxBraid™ Polyethylene Plus Suture. Both types are supplied in lengths of 38" with or without attached suturing needles. The suture is size 2 in keeping with currently recognized United States Pharmacopoeia (USP) standards. Both white and blue suture will be marketed. The suture is coated with silicone in order to ease passage through tissue. When desired, the MaxBraid™ Polyester Plus and Polyethylene Plus Suture may be used with a commercially available suture anchor.

Intended Use: MaxBraid™ Polyester Plus and Polyethylene Plus Sutures are indicated for general soft tissue approximation and/or ligation

Summary of Technologies: The overall design, materials and processing are similar to the predicate device.

Non-Clinical Testing: Testing demonstrated that MaxBraid™ Suture met or exceeded the USP 24 standards for nonabsorbable sutures and are substantially equivelent to the predicate devices.

Clinical Testing: None provided

All trademarks are property of Biomet, Inc. FiberWIRE is a trademark of Arthrex, Inc.

> MAILING ADDRESS 56 E. Bell Drive Warsaw, IN 46581 0587

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EMAIL [e-mail]

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract eagle or bird-like figure with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 2004

Arthrotek, Inc. c/o Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0578

Re: K033718

Trade/Device Name: MaxBraid™ Polyethylene Plus and Polyester Plus Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(cthylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: November 25, 2003 Received: November 26, 2003

Dear Ms. Beres:

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 Fedcral 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. Patricia Sandborn Bercs

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, pcrmits your device to proceed to the market.

If you desire spccific 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,

Miriam C. Provost

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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## Indications for Use

510(k) Number (if known): K033718

Device Name: MaxBraid™ Polyethylene Plus and Polyester Plus Suture

Indications For Use: MaxBraid™ Polyethylene Plus and Polyester Plus suture is indicated for general soft tissue approximation and/or ligation

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

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**510(k) Number** K633718