DIGIFIX EXTERNAL FIXATION SYSTEM

K132731 · Virak Orthopedic Research, LLC · JEC · Jan 10, 2014 · Orthopedic

Device Facts

• Record ID: K132731
• Device Name: DIGIFIX EXTERNAL FIXATION SYSTEM
• Applicant: Virak Orthopedic Research, LLC
• Product Code: JEC · Orthopedic
• Decision Date: Jan 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DIGIFIX™ External Fixation System is intended to be used in skeletally mature patients in treatment of: DYNAMIC MODE: 1) complex fracture-dislocations or fracture-subluxation, unstable dislocations, and pilon fractures of the interphalangeal (IP) joint; 2) Post-traumatic joint contracture of the proximal interphalangeal (PIP) joint; STATIC MODE: 1) comminuted fractures of the phalanges and 2) interphalangeal (IP) joint arthrodesis.

Device Story

External fixation system for finger fractures/joint conditions; includes brackets, locking pins, set screws, and k-wires. Assembled intraoperatively to create frame supporting k-wires on medial/lateral aspects of finger. Used in dynamic mode for dislocations/contractures or static mode for fractures/arthrodesis. Operated by surgeons in clinical setting. Provides mechanical stabilization of phalangeal bones/joints. Benefits patient by maintaining alignment and supporting healing of complex finger injuries.

Clinical Evidence

No clinical data. Bench testing only; substantial equivalence supported by design and material comparison to predicate devices.

Technological Characteristics

External fixation system comprising brackets, locking pins, set screws, and k-wires. Components provided non-sterile for single use. Reusable instruments (pin placement guide, expander, pliers, driver, bender, cutter) provided non-sterile. Mechanical fixation principle.

Indications for Use

Indicated for skeletally mature patients requiring treatment for complex IP joint fracture-dislocations, fracture-subluxations, unstable dislocations, pilon fractures, post-traumatic PIP joint contracture, comminuted phalangeal fractures, or IP joint arthrodesis.

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

• AREX® Ligamentotaxor (K094043)
• Smith & Nephew® COMPASS® HINGE External Fixator (K970713)
• Smith & Nephew® Jet-X® Bar System Clamps, Bars and Posts (K072212)
• BIOMET® BioSymMetric Proximal Interphalangeal Joint Fixator (K980370)

Submission Summary (Full Text)

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K132731 (1/2)

# JAN 10 2014

# 510(k) Summary DigiFix™ External Fixation System January 9, 2014

| Company: | Virak Orthopedic Research LLC<br>115 Fairfield Avenue<br>Short Hills, NJ 07078 USA<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment<br>Registration: | To be completed prior to distribution |
| Primary Contact: | Kimberly Strohkirch<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Company Contact: | Dr. Virak Tan, President and CEO |
| Trade Name: | DigiFix™ External Fixation System |
| Common Name: | Smooth or threaded bone fixation fastener |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3040 |
| Panel: | 87 - Orthopedic |
| Product Code: | IEC, Component, Traction, Invasive |

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#### Device Description:

The DigiFix™ External Fixation System includes various elements including brackets, locking pins, set screws and k-wires. The elements are used to create an assembled frame which capture and support the k-wires on the medial and lateral aspect of finger. The brackets, locking pins and set screws are assembled intraoperatively. External fixator components are provided non-sterile and are intended for single use only.

#### Instrument System

Instruments used with the DigiFix" External Fixation System include the following: Pin Placement Guide, Bracket Expander, Bracket Pliers, Hex Driver, Wire Bender and Wire Cutter. The instruments are reusable and provided non-sterile.

#### Indications for Use:

The DIGIFIX™ External Fixation System is intended to be used in skeletally mature patients in treatment of:

#### DYNAMIC MODE:

1) complex fracture-dislocations or fracture-subluxation, unstable dislocations, and pilon fractures of the interphalangeal (IP) joint;

2) Post-traumatic joint contracture of the proximal interphalangeal (PIP) joint;

#### STATIC MODE:

1) Fractures of the phalanges and 2) interphalangeal (IP) joint arthrodesis.

#### Substantial Equivalence:

K094043 - AREX® Ligamentotaxor K970713 - Smith & Nephew® COMPASS® HINGE External Fixator K072212 - Smith & Nephew® Jet-X® Bar System Clamps, Bars and Posts - MR Cond K980370 - BIOMET® BioSymMetric Proximal Interphalangeal Joint Fixator

The intended use, indications for use, material, surgical technique and dimensions of the subject devices are substantially equivalent to the predicate devices.

#### Performance Testing:

FDA's Guidance for Orthopedic External Devices (2/21/1997) was used as a framework for evaluating the safety and effectiveness of the subject device.

A device which has essentially the same design and materials as the predicate should not require testing unless there is new information which raises safety and effectiveness concerns. The DigiFix™ device utilizes materials and has design features that are the predicate devices. Evaluation of the material, dimensions and K-wires demonstrates that the subject device has a higher estimated rigidity than the predicate devices. Thus, no performance testing is necessary to support substantial equivalence of the device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

Public Health Service

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

January 10, 2014

Virak Orthopedic Research, LLC % Kimberly Strohkirch, MSE Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove Bartlett. Tennessee 38133

Re: K132731

Trade/Device Name: DIGIFIX™ External Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JEC Dated: October 11, 2013 Received: October 15, 2013

Dear Ms. Strohkirch:

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

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### Page 2 – Kimberly Strohkirch, MSE

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/ResourcesforYou/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 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,

# Ronald Payean -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

510(k) Number (if known): K132731

Device Name: DIGIFIX™ External Fixation System

Indications for Use:

The DIGIFIX™ External Fixation System is intended to be used in skeletally mature patients in treatment of: DYNAMIC MODE: 1) complex fracture-dislocations or fracture-subluxation, unstable dislocations, and pilon fractures of the interphalangeal (IP) joint; 2) Post-traumatic joint contracture of the proximal interphalangeal (PIP) joint;

STATIC MODE: 1) comminuted fractures of the phalanges and 2) interphalangeal (IP) joint arthrodesis.

| Prescription Use X<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) |
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices