PCL TIGHTROPE

K110123 · Arthrex, Inc. · HTY · Apr 28, 2011 · Orthopedic

Device Facts

• Record ID: K110123
• Device Name: PCL TIGHTROPE
• Applicant: Arthrex, Inc.
• Product Code: HTY · Orthopedic
• Decision Date: Apr 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex PCL TightRope is intended 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. For example, ACL/PCL repair and reconstruction.

Device Story

PCL TightRope is a surgical fixation device consisting of an adjustable non-absorbable suture loop and two titanium buttons. Used by surgeons in orthopedic procedures for bone-to-bone or soft tissue-to-bone fixation, specifically for ligament or tendon repairs like ACL/PCL reconstruction. The device functions as a fixation post or distribution bridge to manage suture tension. It is a mechanical implant; no software or electronic components are involved.

Clinical Evidence

Bench testing only. Mechanical and biomechanical testing, including ultimate load and cyclic displacement, demonstrated substantial equivalence to predicate devices.

Technological Characteristics

Materials: Titanium buttons, non-absorbable synthetic suture. Principle: Mechanical fixation via adjustable suture loop and buttons. Form factor: Implantable fastener. No software, electronics, or energy sources.

Indications for Use

Indicated for fixation of bone-to-bone or soft tissue-to-bone, including use as fixation posts, distribution bridges, or for distributing suture tension during ligament or tendon repair, such as ACL/PCL reconstruction.

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 BioComposite Interference Screw (K071176)
• Arthrex ACL TightRope (K100652)

Submission Summary (Full Text)

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APR 2 8 2011

# K110123

# 1 510(k) Summary of Safety and Effectiveness

| Date Summary Prepared | January 11, 2011 |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA |
| 510(k) Contact | Courtney Smith<br>Regulatory Affairs Project Manager<br>Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA<br>Telephone: [phone], ext. 1720<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | PCL TightRope |
| Common Name | Fastener, fixation, nondegradable, soft tissue<br>Suture, Nonabsorbable, synthetic, polyethylene |
| Product Code -Classification<br>Name<br>CFR | HTY, GAT<br>21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener<br>21 CFR 878.5000: Nonabsorbable poly(ethylene terephthalate) surgical suture. |
| Predicate Device | K071176: Arthrex BioComposite Interference Screw<br>K100652: Arthrex ACL TightRope |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to<br>obtain clearance for the PCL TightRope. |
| Device Description and Intended<br>Use | The proposed PCL TightRope consists of an adjustable non-<br>absorbable suture loop, and 2 titanium buttons.<br><br>The Arthrex PCL TightRope is intended to be used for<br>fixation of bone to bone or soft tissue to bone, and is intended<br>as fixation posts, a distribution bridge, or for distributing<br>suture tension over areas of ligament or tendon repair. For<br>example, ACL/PCL repair and reconstruction. |
| Substantial Equivalence<br>Summary | The PCL TightRope is substantially equivalent to the<br>previously cleared Arthrex ACL TightRope, in which the basic<br>features and intended use are the same. It is substantially<br>equivalent to the performance characteristics of the previously<br>cleared Arthrex BioComposite Interference Screw, which is<br>cleared for the same indications. Any differences between the<br>PCL TightRope and the predicates are considered minor and<br>do not raise questions concerning safety and effectiveness |

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## KII DIZ 3

The proposed devices consist of a titanium button and nonabsorbable suture which is substantially equivalent to the previously cleared Arthrex ACL TightRope. The submitted data demonstrated that the mechanical and biomechanical testing of the proposed devices is substantially equivalent to the ultimate load and cyclic displacement of the previously cleared Arthrex BioComposite Interference Screw. Based on the indication for use, technological characteristics, and the comparison with the predicate devices, Arthrex, Inc. has determined that the PCL TightRope is substantially equivalent to currently marketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like strokes, positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The text is arranged in a circular fashion around the bird symbol.

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

Arthrex, Inc. % Ms. Courtney Smith Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945

APR 2 8 2011

Re: K110123 Trade/Device Name: Arthrex PCL TightRope Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY, GAT Dated: March 30, 2011 Received: April 5, 2011

Dear Ms. Smith:

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. Insting 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Ms. Courtney Smith

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/RcportaProblem/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,

Ay B. Rota
for

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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## Indications for Use

510(k) Number (if known): 《 | | ○ | 乙 3

Arthrex PCL TightRope Device Name:

Indications For Use:

The Arthrex PCL TightRope is intended 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. For example, ACL/PCL repair and reconstruction.

AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ Prescription Use _V (21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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for M. Mellersor

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

5:0(k) Number K1 0123