TENSYN BAND

K133858 · Dallen Medical, Inc. · HTN · Feb 28, 2014 · Orthopedic

Device Facts

• Record ID: K133858
• Device Name: TENSYN BAND
• Applicant: Dallen Medical, Inc.
• Product Code: HTN · Orthopedic
• Decision Date: Feb 28, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Tensyn™ Band is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures which have been properly stabilized and which allow stable placement of the Tensyn band apart from any other fixation hardware.

Device Story

Tensyn Band is a knotless fixation system for syndesmosis disruptions. Device consists of polymer-coated flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a lock. Available in titanium and stainless steel. Used by surgeons in clinical/OR settings to provide fixation during healing of syndesmotic trauma. Operates by securing the suture band between metal fasteners to stabilize the syndesmosis. Provides mechanical fixation to support bone healing. Benefits patient by maintaining stable syndesmotic reduction during recovery.

Clinical Evidence

Bench testing only. Testing included rotational loading, cyclic loading, ultimate load, load at 3 mm, and shear testing to demonstrate mechanical performance and substantial equivalence to predicate devices.

Technological Characteristics

Knotless fixation system; polymer-coated flat polyethylene terephthalate (PET) suture band; titanium or stainless steel buttons/locks; low-profile design. Mechanical fixation principle.

Indications for Use

Indicated for patients with syndesmotic trauma, specifically syndesmosis disruptions associated with Weber B and C ankle fractures requiring fixation during the healing process.

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

• Tenysn Band (K131850)
• Tightrope Syndesmosis Repair Kit, Titanium, Model Ar-8920Ds; Stainless Steel. Model Ar-8921Ds (K043248)
• ToggleLoc System (K083070)
• Compressyn Band (K130431)

Submission Summary (Full Text)

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K133858

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

# GENERAL INFORMATION

| APPLICANT: | Dallen Medical, Inc.<br>1046 Calle Recodo, Suite G<br>San Clemente, CA 92673<br>[phone] Phone<br>[phone] Fax |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Al Memmolo<br>Chief Operating Officer |
| DATE PREPARED: | February 27, 2014 |
| DEVICE DESCRIPTION: | |
| TRADE NAME: | Tensyn™ Band |
| MODEL: | 09-0025, 09-0026, 09-0027, 09-0028 |
| GENERIC/COMMONNAME | Button / Lock / Suture |
| CLASSIFICATION NAME: | Washer, Bolt Nut, CFR 888.3030 (code HTN) |
| DEVICE CLASSIFICATION: | Class II |
| PREDICATE DEVICES: | Tenysn Band (K131850)<br>Tightrope Syndesmosis Repair Kit, Titanium, Model<br>Ar-8920Ds; Stainless Steel. Model Ar-8921Ds (K043248)<br>ToggleLoc System (K083070)<br>Compressyn Band (K130431) |

# Product Description:

The Tensyn™ Band is a knotless system for fixation of syndesmosis disruptions. The Tensyn "M Band is a low profile system comprised of a polymer coated flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a lock. The Tensyn™ Band is available in titanium and stainless steel.

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# Indications for Use:

Tensynth Band is intended to provide fixation during the healing process following a syndesmotic trauma. such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures which have been properly stabilized and which allow stable placement of the Tensyn band apart from any other fixation hardware.

## Technical Characteristics:

The Tensyn™ Band has similar physical and technical characteristics to the predicate devices since all devices achieve fixation through a suture between two metal fasteners.

## Performance Data:

All necessary testing has been performed with the Tensyn™ Band to assure substantial equivalence to the predicate devices. Testing included rotational loading, cyclic loading, ultimate load, load at 3 mm and shear test. The testing demonstrated that the Tensyn™ Band is substantially equivalent to the predicate devices.

## Basis for Determination of Substantial Equivalence:

Upon reviewing the technical information provided in this submission and comparing intended use, principle of operation, performance data, and overall technological characteristics, the Tensyn™ Band is determined to be substantially equivalent to existing legally marketed devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public I lealth Service

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

February 28, 2014

Dallen Medical. Incorporated Mr. Al Memmolo Chief Operating Officer 1046 Calle Recodo. Suite G San Clemente. California 92673

Rc: K133858

Trade/Device Name: Tensyn™ Band 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: January 2, 2014 Received: January 3, 2014

Dear Mr. Memmolo,

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 docs not mean that FDA has made a determination that your device complics 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

Image /page/2/Picture/11 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three curved lines representing its body and wings. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

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#### Page 2 – Mr. Al Memmolo

forth in the quality systems (OS) regulation (2) 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/ResourcesforYou/Industry/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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Vincent J. Devlin -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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#### Indications for Use Statement

Page 1 of 1

510(k) Number (if known): _K133858

Device Name: Tensyn™ Band

Indications for Use:

Tensyn™ Band is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures which have been properly stabilized and which allow stable placement of the Tensyn band apart from any other fixation hardware.

Prescription Use _ X (Per 21 CFR 801.109) OR

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________

(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.

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Division of Orthopedic Devices