INVISIKNOT Ankle Syndesmosis Repair Kit

K162996 · Smith & Nephew, Inc. · HTN · Jun 8, 2017 · Orthopedic

Device Facts

• Record ID: K162996
• Device Name: INVISIKNOT Ankle Syndesmosis Repair Kit
• Applicant: Smith & Nephew, Inc.
• Product Code: HTN · Orthopedic
• Decision Date: Jun 8, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit is intended to provide fixation as an adjunct to fracture repair hardware during the healing period following an ankle syndesmotic trauma with fracture.

Device Story

The INVISIKNOT Ankle Syndesmosis Repair Kit is a sterile, single-use implant construct used by surgeons in an operating room setting to stabilize ankle syndesmotic trauma. The device consists of a lateral button, a medial button, two stainless steel fixation devices, and an ultrahigh molecular weight polyethylene (UHMWPE) suture tape featuring a one-way sliding knot. A polyester suture is included to assist in passing the medial button from the lateral to the medial side, alongside a 3.5 mm drill tip passing pin for bone preparation. The surgeon uses the passing pin to create a channel through the fibula and tibia, then delivers the medial button through the eyelet. The sliding knot mechanism allows the surgeon to reduce the syndesmosis and secure the construct. By providing supplemental fixation, the device supports the healing process of the ankle syndesmosis alongside primary fracture hardware.

Clinical Evidence

Bench testing only. Mechanical testing evaluated construct performance under expected loading conditions and the structural integrity of the 3.5mm drill tip passing pin. Results demonstrated after-fatigue displacement and deployment performance equivalent to predicate devices. Bacterial endotoxin testing (LAL Kinetic Chromogenic method) confirmed levels <20 EU/device.

Technological Characteristics

Implant construct comprising stainless steel fixation buttons and UHMWPE suture tape. Includes a 3.5 mm drill tip passing pin for bone preparation. Sterile, single-use. Operates via a two-button tensioning system connected by flexible suture material to reduce syndesmotic trauma. No software or electronic components.

Indications for Use

Indicated for patients requiring fixation as an adjunct to fracture repair hardware during the healing period following ankle syndesmotic trauma with fracture.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Biomet Sport Medicine ToggleLoc System (K083070)

Reference Devices

• Smith & Nephew ULTRATAPE (K132357)

Submission Summary (Full Text)

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June 8, 2017

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

Smith & Nephew, Inc. Gregory Neal Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810

Re: K162996

Trade/Device Name: INVISIKNOT Ankle Syndesmosis Repair Kit Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HTN Dated: April 28, 2017 Received: May 5, 2017

Dear Mr. Gregory Neal:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 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,

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

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

510(k) Number (if known) K162996

Device Name INVISIKNOT Ankle Syndesmosis Repair Kit

Indications for Use (Describe)

The Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit fracture device is indicated to provide fixation as an adjunct to fracture repair hardware during the healing period following an ankle syndesmotic trauma with fracture.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# K162996 Page 1 of 2

Endoscopy Smith & Nephew 150 Minuteman Road Andover, MA 01810

978 749 1000 978 749 1443 Fax www.smith-nephew.com

Image /page/3/Picture/3 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The words "We are" are in gray, while "smith&nephew" is in orange, matching the color of the flower symbol.

# 510(k) Summary

| SUBMITTER INFORMATION | CONTACT INFORMATION |
|-----------------------|--------------------------------------|
| Smith & Nephew, Inc. | Gregory Neal |
| 150 Minuteman Road | Senior Regulatory Affairs Specialist |
| Andover, MA 01810 | Phone: [phone] |
| | Fax: [phone] |

| DEVICE NAME (UNMODIFIED) | |
|---------------------------|-----------------------------------------|
| Trade or proprietary name | INVISIKNOT Ankle Syndesmosis Repair Kit |
| Common or usual name | Soft Tissue Fixation Device |
| Classification name | 21 CFR §888.3030 |
| Device Class | Class II |
| Product Code | HTN |

## LEGALLY MARKETED PREDICATE DEVICE

The Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed devices in commercial distribution:

| Predicate Device | 510(k) Number | Clearance Date | Predicate Type |
|----------------------------------------|---------------|----------------|----------------|
| Biomet Sport Medicine ToggleLoc System | K083070 | 12/16/2008 | Primary |
| Smith & Nephew ULTRATAPE | K132357 | 10/30/2013 | Reference |

## DEVICE DESCRIPTION

Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit is a sterile, single-use, implant construct. The implants are composed of three components: a Plug type lateral button and a medial button, two stainless steel fixation devices and an ultrahigh molecular weight polyethylene (UHMWPE) suture tape. The suture tape has a one-way sliding knot to facilitate reduction. The kit also contains a polyester suture attached to one of the fixation devices to enable passing the medial button from the lateral side to the medial side and a 3.5 mm drill tip passing pin to enable preparation of the fibula and the tibula and the tibia. The eyelet in the passing pin enables delivery of the medial button from the lateral side.

## INTENDED USE

The Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit is intended to provide fixation as an adjunct to fracture repair hardware during the healing period following an ankle syndesmotic trauma with fracture.

#### INDICATIONS FOR USE

The Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit fracture device is indicated to provide fixation as an adjunct to fracture repair hardware during the healing period following an ankle syndesmotic trauma with fracture.

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#### TECHNOLOGICAL CHARACTERISTICS

Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit is substantially equivalent in intended use and fundamental scientific technology to the legally marketed predicate device (Biomet ToggleLoc (K083070)) and raises no new issues of safety and efficacy. The predicate device shares operating principles - two buttons connected by a flexible material that can be used to reduce a syndesmotic trauma.

#### SUMMARY OF PERFORMANCE DATA

Mechanical testing to evaluate whether the performance of Smith and Nephew INVISINKOT Ankle Syndesmosis Repair constructs can withstand the expected loading conditions during the healing period following an ankle syndesmosis trauma occurred. Whether the 3.5mm drill tip passing pin required to deploy the implant can withstand use without breaking was also evaluated. Data for after-fatigue displacement and passage of the device from the medial to lateral side demonstrate the INVISIKNOT Ankle Syndesmosis Repair Kit is substantially equivalent to the currently marketed predicate devices.

Bacterial endotoxin testing has been conducted for the subject devices using the LAL Kinetic Chromogenic method. The subject devices have been found to meet the acceptable endotoxin limit of <20 EU/ device.

#### SUBSTANTIAL EQUIVALENCE INFORMATION

The substantial equivalence of the INVISIKNOT Ankle Syndesmosis Repair Kit is based on similarities in indications for use, design features, operational principles, material composition, and performance to the predicate devices listed above. Based on the similarities to the predicates, the INVISIKNOT Ankle Syndesmosis Repair Kit is substantially equivalent to its predicates.