VILEX X-FIX

K052196 · Vilex, Inc. · KTT · Nov 22, 2005 · Orthopedic

Device Facts

• Record ID: K052196
• Device Name: VILEX X-FIX
• Applicant: Vilex, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Nov 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• 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

Vilex X-Fix is an external ring fixation system used by orthopedic surgeons for bone stabilization and deformity correction. The device provides mechanical support to bone segments to facilitate healing or structural realignment. It is utilized in clinical settings for fracture management, arthrodesis, and limb lengthening procedures. The system functions as a rigid frame to maintain bone position during the healing process, aiding patient recovery through controlled stabilization.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

External ring fixation system consisting of bone implants and surgical instruments. Mechanical stabilization principle. Materials and specifications are consistent with standard orthopedic external fixation hardware.

Indications for Use

Indicated for adult and pediatric patients requiring stabilization of fractures and osteotomies, rear and mid-foot arthrodesis, leg lengthening, and correction of bone deformities in upper and lower extremities.

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

• R&R Medical, Inc. (K043174)
• Orthofix (K955848)
• EBI (K970290)

Submission Summary (Full Text)

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K052196 Page 1/1

Image /page/0/Picture/2 description: The image shows the logo for Vilex Inc. The logo consists of the word "VILEX" in a bold, stylized font, with the letters connected and a line underneath. To the right of the logo is the abbreviation "Inc." The text below the logo states that Vilex is a manufacturer of bone implants, power equipment, and surgical instruments.

Phone: [phone]
FAX: [phone] www.vilex.com

345 Old Curry Hollow Road
Pittsburgh, PA 15236 USA
E-mail: [e-mail]

## 510(K) SUMMARY SUMMARY
Vilex External Fixation System, X-Fix

| Date of submission | 6/7/05 |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of submission | 510(k) |
| Reason for submission | New device |
| Product Code | KTT, JDW CFR-21 888.3030, CFR-21 888.3040 |
| Device Class | I |
| Classification Panel | Orthopedics |
| Predicate Devices:<br>K043174<br>K955848<br>K970290 | R&R Medical, Inc.<br>Orthofix<br>EBI |
| Common/Generic | External Ring Fixation |
| Device Trade Name | Vilex External Fixation System, X-Fix |
| Establishment Reg. No. | 2529556 |
| Owner Operator No. | 9004058 |
| Establishment<br>Operations | Manufacturer |
| Indication for Use | The Vilex X-Fix is intended for external fixation with the following indications:<br>1. Stabilization of Fractures & Osteotomy<br>2. Rear & Mid-foot Foot Arthrodesis<br>3. Adult and Pediatric Leg Lengthening<br>4. Correction of Bone Deformity in Upper & Lower Extremities. |
| Submitter | A. Lavi |

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features the HHS emblem, which is a stylized representation of a human figure. The emblem is accompanied by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 2 2005

Dr. Abraham Lavi, Ph.D., M.B.A. President Vilex, Inc. 345 Old Curry Hollow Road Pittsburgh, Pennsylvania 15236

Re: K052196

Trade/Device Name: X-Fix Regulation Number: 21 CFR 888.3030 Regulation Name: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Regulatory Class: II Product Codes: KTT, JDW Dated: October 05, 2005 Received: October 27, 2005

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Dr. Abraham Lavi, Ph.D., M.B.A.

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely vours,

Z

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/3/Picture/0 description: The image shows the logo for VILEX Inc. The logo is in a rectangular box with the word "VILEX" in bold, black letters. The letters are stylized, with the "I" and "E" connected by a horizontal line. To the right of the box, the word "Inc." is written in a smaller, non-bold font.

Manufacturer of Vilex™ bone implants, Power equipment & surgical instruments.

Phone: [phone] FAX: [phone] www.vilex.com

345 Old Curry Hollow Road Pittsburgh, PA 15236 USA E-mail: [e-mail]

## INDICATIONS FOR USE:

510(K) NUMBER: K052196

DEVICE NAME: VILEX EXTERNAL FIXATION SYSTEM

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.

X Prescription Use: (21 CFR 801 Subpart D)

Over-The-Counter Use NONE (21 CFR 801 Subpart C)

(Please Do Not Write Below This Line-Continue On Another Page If Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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**510(k) Number** [C052196