RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM

K130814 · Depuy Mitek, A Johnson & Johnson Company · MBI · Aug 1, 2013 · Orthopedic

Device Facts

• Record ID: K130814
• Device Name: RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM
• Applicant: Depuy Mitek, A Johnson & Johnson Company
• Product Code: MBI · Orthopedic
• Decision Date: Aug 1, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RIGIDLOOP™ Cortical Fixation System is used for the fixation of soft tissue to bone in orthopedic procedures such as ACL repair.

Device Story

The RIGIDLOOP Cortical Fixation System is a machined titanium implant used for soft tissue-to-bone fixation in orthopedic procedures like ACL repair. The device consists of a titanium button with a pre-attached non-absorbable fiber loop and an auxiliary suture for placement assistance; the auxiliary suture is discarded after implantation. It is available in 15-60mm sizes. Reusable reamers and depth gauges are used as accessories for placement. The device is intended for use by surgeons in a clinical/OR setting. It functions as a mechanical fastener to secure ligaments or tendons to bone, providing stability during the healing process.

Clinical Evidence

Bench testing only. Verification activities included pull-out testing, shelf-life, sterilization, and biocompatibility assessments. No clinical data was provided.

Technological Characteristics

Machined titanium implant; non-absorbable fiber loop; non-absorbable suture. Sizes 15-60mm in 5mm increments. Mechanical fixation principle. Reusable accessories (reamers, depth gauges).

Indications for Use

Indicated for patients requiring soft tissue to bone fixation during orthopedic procedures, such as 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

• Smith & Nephew EndoButton Continuous Loop (K980155)
• Smith & Nephew EndoButton Continuous Loop (K081098)
• Fastin RC Anchors (K060664)
• Orthocord suture (K040004 / K042398)

Submission Summary (Full Text)

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### SECTION 2 - 510(k) SUMMARY RIGIDLOOP Cortical Fixation System

| Recognized<br>Manufacturer: | Medos International SarL<br>Puits Godet 20<br>CH 2000 Neuchâtel<br>Switzerland |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | DePuy Mitek, Inc.<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767<br>Date Prepared: April 17, 2013 |
| Contact Person | Kristine Christo<br>Manager, Regulatory Affairs<br>DePuy Mitek, Inc.<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767, USA |
| | AUG 1 2013<br>Telephone: [phone]<br>Facsimile: 508-977-6911<br>e-mail: [e-mail] |
| Name of<br>Medical Device | Proprietary Name: RIGIDLOOP Cortical Fixation System<br>Classification Name: Fastener, Fixation, Nondegradable, Soft tissue<br>Common Name: Fastener, Fixation, Soft Tissue |
| Substantial<br>Equivalence | The RIGIDLOOP Cortical Fixation Systemis substantially equivalent to:<br>• K980155 Smith & Nephew EndoButton Continuous Loop<br>• K081098 Smith & Nephew EndoButton Continuous Loop<br>• K060664 Fastin RC Anchors<br>• K040004 / K042398 Orthocord suture |
| Device<br>Classification | Smooth or threaded metallic bone fixation fastener, classified as Class II, product code<br>MBI regulated under 21 CFR 888.3040. |

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| Device<br>Description | The RIGIDLOOP Cortical Fixation System is a machined titanium implant designed<br>to provide fixation in the repair of tendons and ligaments. It consists of a titanium<br>implantable button with a pre-attached non-absorbable fiber loop. This implantable<br>fiber loop has non-absorbable suture attached to the button for assisting in the button<br>placement and is discarded after the device placement. The device is offered in size<br>ranges of 15-60mm in 5mm increments.<br>Reamers and depth gauges are provided separately as reusable accessories to assist in<br>the placement of the RIGIDLOOP Cortical Fixation System. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | The proposed RigidLoop Fixation Device consists of similar materials and design as<br>predicate Smith & Nephew Endobutton Cl (K980155, K081098). The proposed device<br>principal operation is identical to predicate Smith &Nephew Endobutton CL<br>(K980155, K081098). The RigidLoop Cortical Fixation Device has no new<br>technological characteristics as compared to the predicate Smith &Nephew<br>Endobutton CL (K980155, K081098). |
| Indications for<br>Use | The RIGIDLOOP™ Cortical Fixation System is used for the fixation of soft tissue to<br>bone in orthopedic procedures such as ACL repair. |
| Non clinical<br>Testing | Verification activities were performed on the implant and / or its predicates. Testing<br>assessments include pull out testing, shelf-life, sterilization and biocompatibility. |
| Safety and<br>Performance | Results of performance testing have demonstrated that the proposed devices are<br>suitable for their intended use.<br>Based on the indications for use, technological characteristics, and comparison to the<br>predicate devices, the proposed RIGIDLOOP Cortical Fixation System has shown to<br>be substantially equivalent to the predicate devices under the Federal Food, Drug and<br>Cosmetic Act. |

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three wing-like shapes.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

August 1, 2013

DePuy Mitek, Incorporated % Ms. Kristine Christo Manager, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767

Re: K130814

Trade/Device Name: RigidLoop 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 27, 2013 Received: July 2, 2013

Dear Ms. Christo:

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 (2 1 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

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#### Page 2 -- Ms. Kristine Christo

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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

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

Sincerely yours,

## Mark N. Melkerson -S

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

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# Indications for Use

510(k) Number (if known): K130814 Device Name: RigidLoop Cortical Fixation System

Indications for Use:

The RIGIDLOOP™ Cortical Fixation System is used for the fixation of soft tissue to bone in orthopedie . procedures such as ACL repair.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use _____________________________________________________________________

(Part 21 CFR 801 Subpart D)

(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)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

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