ACL TIGHTROPE

K100652 · Arthrex, Inc. · HTY · Jun 23, 2010 · Orthopedic

Device Facts

• Record ID: K100652
• Device Name: ACL TIGHTROPE
• Applicant: Arthrex, Inc.
• Product Code: HTY · Orthopedic
• Decision Date: Jun 23, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ACL TightRope is to be used for fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering this for Anterior Cruciate Ligament (ACL) Repair.

Device Story

ACL TightRope is a surgical fixation device consisting of a titanium button and an adjustable non-absorbable suture loop. Used by orthopedic surgeons in clinical settings for ligament or tendon repair, specifically ACL reconstruction. The device functions as a fixation post or distribution bridge to secure soft tissue to bone or bone to bone. The adjustable loop allows for tensioning during the procedure, distinguishing it from predicate devices with constant loop lengths. The surgeon implants the device to provide mechanical stability during the healing process. Benefit includes secure fixation of graft tissue to bone.

Clinical Evidence

Bench testing only. Mechanical testing was performed to compare ultimate load and cyclic displacement of the ACL TightRope against predicate devices, demonstrating substantial equivalence.

Technological Characteristics

Device consists of a titanium button and non-absorbable synthetic polyethylene suture. Features an adjustable suture loop mechanism. Designed for bone-to-bone or soft tissue-to-bone fixation. Mechanical performance is characterized by ultimate load and cyclic displacement metrics.

Indications for Use

Indicated for fixation of bone-to-bone or soft tissue-to-bone, specifically for Anterior Cruciate Ligament (ACL) repair.

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

• Arthrex RETROBUTTON™ (K062747)
• Arthrex Fiberwire® Button Repair Kit (K031666)

Submission Summary (Full Text)

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## K100452 p. 10f2

Arthrex SPECIAL 510(K): Arthrex ACL TIghtRope

JUN 2 8 LUN

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# 4 510(k) Summary of Safety and Effectiveness

| Date | May 20, 2010 |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/Distributor<br>/Sponsor | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA |
| 510(k) Contact | Geena Augustine<br>Quality Engineer<br>Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA<br>Telephone: [phone], ext. 2207<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | ACL TightRope |
| Common Name | Pin, fixation, smooth<br>Suture, Nonabsorbable, synthetic, polyethylene |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation<br>fastener<br>21 CFR 878.5000: Nonabsorbable poly(ethylene terephthalate<br>surgical suture. |
| Product Code -<br>Classification Name | GAT - Nonabsorbable poly(ethylene terephthalate) surgical<br>suture.<br>HTY- Smooth or threaded metallic bone fixation fastener. |
| Predicate Devices | K062747: Arthrex RETROBUTTON™<br>K031666: Arthrex Fiberwire® Button Repair Kit |
| Device Description and<br>Intended Use | The ACL TightRope consists of an adjustable non-absorbable<br>suture loop and titanium button.<br>The ACL TightRope is to be used for fixation of bone to bone or<br>soft tissue to bone, and is intended as fixation posts, a<br>distribution bridge, or for distributing suture tension over areas of<br>ligament or tendon repair. Specifically, Arthrex will be offering<br>this for Anterior Cruciate Ligament (ACL) Repair. |
| Substantial Equivalence<br>Summary | The ACL TightRope is substantially equivalent to the predicate<br>devices in which the intended uses is the same and basic features<br>are very similar. Any differences between the ACL TightRope<br>and the predicate devices are considered minor and do not raise<br>questions concerning safety and effectiveness. |

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Arthrex SPECIAL 510(k): Arthrex ACL TightRope

| The proposed device contains a titanium button and non-absorbable suture which are similar to the predicate devices. The proposed device contains an adjustable suture loop when compared to the predicate devices which contain constant loop lengths. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| From the mechanical testing completed the ultimate load and cyclic displacement are substantially equivalent for the proposed device when compared to the predicate devices. |
| Based on the indication for use, technological characteristics and the comparison to the predicate device, Arthrex, Inc. has determined that the ACL TightRope is substantially equivalent to the currently marketed predicate devices. |

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission of providing essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Arthrex, Inc. c/o Ms. Geena Augustine Quality Engineer 1370 Creekside Boulevard Naples, Florida 34108-1945

JUN 2 8 2010

Re: K100652

Trade/Device Name: ACL TightRope Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY, GAT Dated: May 21, 2010 Received: May 24, 2010

Dear Ms. Augustine:

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 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

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Page 2 - Ms. Geena Augustine

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.

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/CDRHOffices/ucm115809.html 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 yours,

Barbara Boehm

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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SPECIAL 510(k): Arthrex ACL Tight|Rope

### Indications for Use Form

#### Indications for Use

510(k) Number:

K100652

Device Name:

ACL TightRope

The ACL TightRope is to be used for fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering this for Anterior Cruciate Ligament (ACL) Revair.

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)

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Orita for mxm

(Davision Sign-Off) Division of Surgica! Orthopedic, and Restorative Devices

510(k) Number K100652