ARTHREX SUTURE (UHMWPE)

K122374 · Arthrex, Inc. · GAT · Sep 25, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K122374
• Device Name: ARTHREX SUTURE (UHMWPE)
• Applicant: Arthrex, Inc.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Sep 25, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex Suture is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft or autograft tissue are used for repair.

Device Story

Arthrex Suture is a braided surgical suture construct composed of 100% UHMWPE; black-dyed strands contain nylon. Suture ends are stiffened with cyanoacrylate. Supplied in pre-cut lengths with or without swaged needles; available in straight and loop configurations; sizes #2 to #5 for suture and 1.5mm to 4mm for tape. Used by surgeons in clinical settings for soft tissue approximation and ligation. Device provides mechanical fixation during surgical repair, potentially improving tissue healing outcomes by maintaining approximation.

Clinical Evidence

Bench testing only. Mechanical testing demonstrated that the device meets or exceeds established minimum acceptance criteria for tensile (pull-out) strength and knot pull.

Technological Characteristics

Braided construct of 100% UHMWPE; black strands contain nylon. Ends stiffened with cyanoacrylate. Meets USP standards for suture. Sizes: #2 to #5 (suture), 1.5mm to 4mm (tape).

Indications for Use

Indicated for soft tissue approximation and/or ligation in patients undergoing surgical procedures, including those utilizing allograft or autograft tissue for repair.

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 and FiberTape (K041553)
• ACL TightRope (K100652)

Submission Summary (Full Text)

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Arthrex SPECIAL 510(k): Arthrex Suture

| 510(k) Summary | |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Summary Prepared | September 20, 2012 |
| Purpose of Submission | To obtain clearance for a line extension to the existing suture<br>devices |
| Manufacturer/Distributor<br>/Sponsor | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA |
| 510(k) Contact | Ivette Galmez<br>Regulatory Affairs Associate<br>Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA<br>Telephone: [phone], ext. 1263<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | Arthrex Suture |
| Common Name | Non-absorbable Surgical Suture |
| Product Code -<br>Classification Name | GAT - 21 CFR 878.5000: Nonabsorbable poly(ethylene<br>terephthalate) surgical suture |
| Predicate Devices | K041553 - Arthrex FiberWire and FiberTape<br>K100652 - ACL TightRope |
| Device Description | The Arthrex Suture is a dyed or non-dyed braided suture<br>construct made of 100% UHMWPE. The Arthrex Suture strands<br>that are dyed black are made of nylon. Suture ends are stiffened<br>with cyanoacrylate. The Arthrex Suture will be supplied in pre-<br>cut lengths with or without various swaged needles. The Arthrex<br>Suture constructs meet USP standards for suture. The Arthrex<br>Suture is available in straight and loop configurations; and sizes<br>#2 to #5 for suture, and 1.5mm to 4mm (width) for tape. |
| Indications for Use | The Arthrex Suture is intended for use in soft tissue<br>approximation and/or ligation. The suture may be provided<br>individually or be incorporated as a component, into surgeries<br>where constructs including those with allograft or autograft tissue<br>are used for repair. |
| Substantial Equivalence<br>Summary | The Arthrex Suture is substantially equivalent to the predicate<br>devices in which the basic features (design configuration, size<br>and width) are similar and the intended use is the same. |
| | |
| Substantial Equivalence<br>Summary (continue) | The main differences between the predicate<br>(FiberWire/FiberTape) and the proposed devices are: |
| | • Fiber Wire is made of UHMWPE and polyester, the proposed<br>device is made of UHMWPE only.<br>• Fiber Wire does not meet the diameter as per USP standards,<br>the UHMWPE suture meets USP.<br>• Fiber Wire sizes range from 4-0 to #5, the UHMWPE suture<br>ranges in size from #2 to #5.<br>• FiberTape sizes range from 2mm to 4mm, the UHMWPE<br>tape ranges in size from 1.5mm to 4mm.<br>• FiberTape ends taper into suture-like strands but the ends of<br>the UHMWPE tape do not. |
| | These differences are considered minor and do not raise<br>questions concerning safety and effectiveness. |
| | The mechanical testing demonstrates that the proposed device<br>meets or exceeds the established minimum acceptance criteria for<br>tensile (pull-out) strength and knot pull for the desired<br>indications. |
| | Based on the indication for use, technological characteristics, and<br>summary of data submitted, Arthrex, Inc. has determined that the<br>Arthrex Suture is substantially equivalent to currently marketed<br>predicate devices. |

SEP 2 5 2012

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K122374
p2/2

Arthrex SPECIAL 510(k): Arthrex Suture

:

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest wings and a body. The overall design is simple and conveys a sense of national identity and governmental authority.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP 2 5 2012

Arthrex Incorporation % Ms. Ivette Galmez Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108

Re: K122374

Trade/Device Name: Arthrex Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) sur-gical suture Regulatory Class: Class II Product Code: GAT Dated: September 10, 2012 Received: September 13, 2012

Dear Ms. Galmez:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA) it may be subject to 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

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## Page 2 – Ms. Ivette Galmez

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. -

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Arthrex. SPECIAL 510(k): Arthrex Suture

## 3 Indications for Use Form

## Indications for Use

510(k) Number (if known):

Device Name: Arthrex Suture

Indications For Use:

The Arthrex Suture is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft or autograft tissue 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 (ODE)

Mal dMele

Sign-Of

(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic, Division of Suices

510(k) Number K122374

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