RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL

K140324 · Depuy Mitek, A Johnson and Johnson Company · MBI · Jul 7, 2014 · Orthopedic

Device Facts

• Record ID: K140324
• Device Name: RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL
• Applicant: Depuy Mitek, A Johnson and Johnson Company
• Product Code: MBI · Orthopedic
• Decision Date: Jul 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RIGIDLOOP Adjustable Cortical Fixation System is indicated for fixation of soft tissue to bone in Femoral Cruciate Ligament Reconstruction.

Device Story

The RIGIDLOOP Adjustable Cortical Fixation System is a sterile, single-use orthopedic implant used in cruciate ligament reconstructive surgery. It consists of a titanium button and adjustable suture loops made of ultra-high molecular weight polyethylene (UHMWPE) and polyester (PET). The device is used by surgeons to secure soft tissue to bone. The surgeon adjusts the length of the suture loops to the desired length during the procedure to achieve fixation. The system provides mechanical stability for the graft during the healing process. It is intended for use in a clinical or surgical setting.

Clinical Evidence

Bench testing only. Fixation strength testing demonstrated performance equivalent to predicate devices. Biocompatibility data confirms the device is suitable for its intended use.

Technological Characteristics

Materials: Titanium button, UHMWPE and PET sutures. Sensing/Actuation: Mechanical fixation via adjustable suture loop. Energy Source: None (manual). Connectivity: None. Sterilization: Sterile, single-use. Form factor: Cortical fixation button with adjustable loop.

Indications for Use

Indicated for patients undergoing Femoral Cruciate Ligament Reconstruction requiring fixation of soft tissue to bone.

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

• ToggleLoc System with ZipLoop Technology (K083070, K130033)
• Milagro Advance Interference Screw (K123362)

Submission Summary (Full Text)

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## 510(k) SUMMARY RIGIDLOOP™ Adjustable Cortical Fixation System

| Date Summary<br>Prepared | February 7, 2014 | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Submitter's<br>Name and<br>Address | Medos International SARL<br>Chemin-Blanc 38, Case Postale<br>CH 2400 Le Locle, Switzerland | |
| Contact Person | Yayoi Fujimaki<br>Regulatory Affairs Senior Associate<br>DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767, USA | Telephone: [phone]<br>Facsimile: 508-977-6911<br>e-mail: [e-mail] |
| Name of<br>Medical Device | Trade Name: | RIGIDLOOPTM Adjustable Cortical Fixation System |
| | Common Name: | Fastener, fixation, nondegradable, soft tissue |
| Device<br>Classification | MBI - Smooth or threaded metallic bone fixation fastener, classified as Class<br>II, regulated per 21 CFR 888.3040.<br>Orthopedic panel | |
| Predicate<br>Device | ToggleLoc System with ZipLoop Technology (K083070, K130033; Biomet<br>Sports Medicine)<br>Milagro Advance Interference Screw (K123362, DePuy Mitek) | |
| Indications for<br>Use | The RIGIDLOOP Adjustable Cortical Fixation System is indicated for fixation<br>of soft tissue to bone in Femoral Cruciate Ligament Reconstruction. | |
| Device<br>Description | The proposed device is a cortical fixation system composed of titanium button,<br>adjustable suture (Ultra-high molecular polyethylene (UHMWPE)), leading<br>suture (UHMWPE and green Polyester (PET) co-braid) and training suture<br>(green PET). Length of the suture loops is adjustable to the desired length.<br>The proposed device provides a fixation in cruciate ligament reconstructive<br>surgery. The device is provided as sterile for single patient use only. | |
| | | |
| Safety and<br>Performance | Non-clinical Testing<br>Fixation strength testing (bench-top) was conducted. The testing demonstrated<br>substantial equivalence of device performance. The proposed device has been<br>determined biocompatible for the intended use based on biocompatibility data.<br>The proposed device has raised no new issue of safety and efficacy. | |
| Substantial<br>Equivalence | The predicate devices have been used for the proposed indications. The<br>proposed device is a cortical fixation device that consists of a titanium button<br>and non-absorbable sutures. Technological characteristics and fixation strength<br>are substantially equivalent to the predicate devices. Differences found between<br>the proposed and the predicate devices are considered minor and do not raise<br>questions concerning safety and efficacy.<br>Based on the indications for use, technological characteristics and comparison<br>with the predicate devices, we determined that the proposed device is<br>substantially equivalent to the predicate devices. | |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 7, 2014

Medos International Sárl % Ms. Yavoi Fujimaki DePuv Mitek, a Johnson & Johnson company 325 Paramount Drive Raynham, Massachusetts 02767

Re: K140324

Trade/Device Name: RIGIDLOOP™ Adjustable Cortical Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: June 4, 2014 Received: June 5, 2014

Dear Ms. Fujimaki:

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 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.

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Page 2 – Ms. Yayoi Fujimaki

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2) CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

## Ronald P. Jean -S for

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

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

#### 510(k) Number (if known) K140324

Device Name

RIGIDLOOPTM Adjustable Cortical Fixation System

Indications for Use (Describe)

The RIGIDLOOP Adjustable Cortical Fixation System is indicated for fixation of soft tissue to bone in Femoral Cruciate Ligament Reconstruction.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
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| Casey L. Hanley, Ph.D. | |
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| Division of Orthopedic Devices | Page 1/1 |

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