INTRAMEDULLARY FIXATION ROD (IFS)

K083458 · Novalign Orthopaedics, Inc. · HSB · Feb 9, 2009 · Orthopedic

Device Facts

• Record ID: K083458
• Device Name: INTRAMEDULLARY FIXATION ROD (IFS)
• Applicant: Novalign Orthopaedics, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Feb 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NovaLign™ Intramedullary Fixation System is intended for use in the fixation of long bone fractures, including fractures in the humerus, femur and the tibia.

Device Story

NovaLign™ Intramedullary Fixation System is a segmented intramedullary nail for long bone fracture fixation. Device functions as a flexible nail during insertion to facilitate placement; transitions to a rigid state upon completion of the surgical procedure to provide stability. Used by surgeons in an operating room setting. Benefits patient by providing adjustable fixation for fractures of humerus, femur, and tibia.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Segmented intramedullary nail design. Materials: Titanium alloy (ASTM F136) and Nitinol (ASTM F2063). Mechanical transition from flexible to rigid state for implantation.

Indications for Use

Indicated for fixation of long bone fractures, including humerus, femur, and tibia fractures in patients requiring intramedullary stabilization.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Submission Summary (Full Text)

{0}------------------------------------------------

.

.

### 510(k) Summary 5.

| Company: | NovaLign™ Orthopaedics, Inc.<br>5885 Ridgeway Center Parkway - Suite 210<br>Memphis, TN 38120<br>Phone: [phone]<br>Fax: [phone] | FEB - 9 2009 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact: | Jeffrey G. Roberts<br>President & CEO | |
| Prepared By: | Musculoskeletal Clinical Regulatory Advisers, LLC<br>1331 H Street, NW, 12th Floor<br>Washington, DC 20005<br>Phone: [phone]<br>Fax: [phone] | |
| Device Name: | Intramedullary Fixation System | |
| Classification: | 21 CFR 888. 3020, Intramedullary fixation rod, Class II | |
| Product Code: | HSB | |
| Device Description: | The NovaLign™ Intramedullary Fixation System is a<br>segmented, intramedullary nail intended for long bone<br>fracture fixation. The device is intended to function as a<br>flexible intramedullary nail during device placement, but<br>will be made rigid at the completion of the surgical<br>implantation procedure. | |
| Intended Use: | The NovaLign™ Intramedullary Fixation System is<br>intended for use in the fixation of long bone fractures,<br>including fractures in the humerus, femur and the tibia. | |
| Materials: | The implants are made from titanium alloy (ASTM<br>F136) and Nitinol (ASTM F2063) | |

:

・・・

.

. .

:

1. 1. 1. 1.

{1}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 9 2009

NovaLign Orthopaedics, Inc. % Mr. Jeffrey G. Roberts President & CEO 5885 Ridgeway Center Parkway - Suite 210 Memphis, Tennessee 38120

Re: K083458

Trade/Device Name: Intramedullary Fixation System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulation Class: Class II Product Code: HSB Dated: January 16, 2009 Received: January 16, 2009

Dear Mr. Roberts:

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 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.

{2}------------------------------------------------

Page 2 - Mr. Jeffrey G. Roberts

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. Commen

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 yours,

Mark N. Millman

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

Enclosure

{3}------------------------------------------------

#### Indications for Use 4.

510(k) Number (if known):

# Device Name: NovaLign™ Intramedullary Fixation System

The NovaLign™ Intramedullary Fixation System is intended for use in the fixation of long bone fractures, including fractures in the humerus, femur and the tibia.

Prescription Use ﺌﮯ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Umm my

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

510(k) Number_ L083458

CONFIDENTIAL