VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES

K132820 · Vilex, Inc. · JDW · Jul 23, 2014 · Orthopedic

Device Facts

• Record ID: K132820
• Device Name: VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES
• Applicant: Vilex, Inc.
• Product Code: JDW · Orthopedic
• Decision Date: Jul 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Vilex X-Fix is intended for external fixation with the following indications: 1. Stabilization of Fractures & Osteotomy 2. Rear & Mid-foot Foot Arthrodesis 3. Adult and Pediatric Leg Lengthening 4. Correction of Bone Deformity in Upper & Lower Extremities

Device Story

Ultima HA Coated Half Pins and Wires are medical-grade stainless steel bone fixation fasteners coated with hydroxyapatite (HA). Used as components in external fixation systems to stabilize fractures, perform osteotomies, facilitate arthrodesis, and correct bone deformities in upper and lower extremities. Operated by surgeons in clinical settings. HA coating promotes osseointegration at the bone-pin interface. Device provides mechanical stability to bone segments during healing or corrective procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by design analysis and material comparison to predicate devices.

Technological Characteristics

Medical grade stainless steel bone fixation fasteners with hydroxyapatite (HA) coating. Mechanical fixation principle. Dimensions and form factors consistent with predicate external fixation pins and wires.

Indications for Use

Indicated for adult and pediatric patients requiring external fixation for fracture stabilization, osteotomy, rear/mid-foot arthrodesis, leg lengthening, and correction of upper/lower extremity bone deformities.

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 Jet-X Half Pins (HA Coated) (K023921, K033289)
• Orthofix External Fixation Screw (Pin) with Hydroxyapatite Coating (K974186)
• Pins used with Mini Rail System (K955848)
• Stryker Apex Pins (K061493)
• Wright Medical Sidekick Rail Half Pins (K080071)
• SBi Mini Rail Half Pins by SBI (K093550)
• Treu Kirschner Wires by Treu-Instrumente GMBH (K083912)

Reference Devices

• Medical Facets Kirschner Wires by Medical Facets (K112727)

Submission Summary (Full Text)

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### 510(k) Summary K132820

### JIII 2 3 2014

| Sponsor: | Vilex in Tennessee, Inc.<br>111 Moffitt St.<br>McMinnville, TN 37110<br>931-474-7550 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Abraham Lavi |
| Date Prepared: | June 16, 2014 |
| Trade Name: | Ultima HA Coated Half Pins & Wires |
| Common Name: | Bone fixation fastener |
| Classification: | 21 CFR 888.3040 - Smooth or threaded memtallic bone fastener |
| Product Code: | JDW/Orthopedics, Class II |
| Predicate Devices: | Smith & Nephew Jet-X Half Pins (HA Coated) (K023921, K033289)<br>Orthofix External Fixation Screw (Pin) with Hydroxyapatite Coating<br>(K974186) and Pins used with Mini Rail System (K955848)<br>Stryker Apex Pins (K061493)<br>Wright Medical Sidekick Rail Half Pins (K080071)<br>SBi Mini Rail Half Pins by SBI (K093550)<br>Treu Kirschner Wires by Treu-Instrumente GMBH (K083912) |

Medical Facets Kirschner Wires by Medical Facets (K112727)

#### Description of Device:

This submission includes medical grade stainless steel half pins and wires coated with Hydroxyapatite (HA). They are intended to be used with external fixation systems.

#### Indications for Use:

The Vilex X-Fix is intended for external fixation with the following indications:

- 1. Stabilization of Fractures & Osteotomy
- 2. Rear & Mid-foot Foot Arthrodesis
- 3. Adult and Pediatric Leg Lengthening

4. Correction of Bone Deformity in Upper & Lower Extremities

#### Technological Characteristics:

The technological characteristics for the Ultima HA Coated Half Pins are Wires are the same as the characteristics of the predicate devices. All of the sizes included in the Vilex Ultima HA Coated Half Pin and Wire system are within the range of offerings of the predicate devices and the designs of the Vilex devices are similar to the predicate devices. The materials used to manufacture the Vilex Ultima devices are the same as those used to manufacture the predicate devices.

#### Substantial Equivalence

The design features of the Ultima HA Coated Half Pins & Wires are substantially equivalent to the design features of other predicate devices previously cleared for market. The methods used to establish equivalence are indications for use, material of construction, sizes, and shapes. The safety and effectiveness of the Ultima HA Coated Half Pins & Wires are adequately supported by

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# 510(k) Summary K132820

the substantial equivalence information, material information and analysis data provided within this Premarket Notification. Therefore, it is concluded that the Ultima HA Coated Half Pins and Wires are substantially equivalent to the noted predicate devices.

### Conclusions

While the Ultima HA Coated Half Pins and Wires are not identical to the predicate devices, any differences that may exist do not significantly affect device safety and effectiveness. In addition, the differences do not add new or increased risks and complications. Therefore, it is concluded that the Ultima HA Coated Half Pins and Wires are substantially equivalent to the predicate devices as outlined previously and should not render the subject device NSE.

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Public Health Service

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

July 23, 2014

Vilex, Incorporated Dr. Abraham Lavi President 7214 Lake Forest Glen Lakewood Ranch, Florida 34202

Re: K132820

Trade/Device Name: Ultima HA Coated Half Pins and Wires Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JDW Dated: June 19, 2014 Received: June 23, 2014

Dear Dr. Lavi:

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 - Dr. Abraham Lavi

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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours, Lori A. Wigqins

for

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

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Vilex Inc. The logo consists of the word "VILEX" in large, bold, black letters, with the "EX" part of the word being stylized. Below the logo, there is text that reads "Manufacturer of Vilex TM bone implants, Power equipment & surgical instruments."

Phone: Fax: www.vilex.com

[phone] [phone]

111 Moffitt Street McMinnville, TN 37110 USA E-mail: [e-mail]

# INDICATIONS FOR USE

510(k) NUMBER: K132820

DEVICE NAME: Ultima HA Coated Half Pins and Wires

# INDICATIONS FOR USE:

The Vilex X-Fix is intended for external fixation with the following indications:

- 1. Stabilization of Fractures & Osteotomy
- 2. Rear & Mid-foot Foot Arthrodesis
- 3. Adult and Pediatric Leg Lengthening
- 4. Correction of Bone Deformity in Upper & Lower Extremities

Prescription Use ਮ (Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (BOE) (ODE)

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Casey L. Hanley, Ph.D.

Division of Orthopedic Devices