ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL

K032367 · Zimmer, Inc. · HSB · Aug 12, 2003 · Orthopedic

Device Facts

• Record ID: K032367
• Device Name: ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL
• Applicant: Zimmer, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Aug 12, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ITST Intramedullary Nail is indicated for use in a variety of femoral fractures, such as: • Subtrochanteric Fractures • Intertrochanteric Fractures • Comminuted Fractures • Segmental Fractures • Fractures with Bone Loss • Proximal and Distal Fractures • Nonunions

Device Story

ITST Intertrochanteric Subtrochanteric Intramedullary Femoral Nail provides reduction and internal fixation of femoral head and neck fractures. Device features curved, tapered intramedullary nail designed to match femoral canal anatomy. Modifications from predicate include features for easier insertion, accommodation of larger lag screw, and addition of sliding and locking nail caps. Used by surgeons in clinical settings for orthopedic fracture management. Benefits include anatomical fit and stable fixation for various femoral fracture types.

Clinical Evidence

No clinical data was required or provided for this device. Substantial equivalence was established through non-clinical performance testing as part of the design assurance procedure.

Technological Characteristics

Intramedullary fixation rod (21 CFR 888.3020). Features curved, tapered nail geometry. Includes sliding and locking nail caps and larger lag screw accommodation. Materials and sterilization processes are identical to the predicate device.

Indications for Use

Indicated for patients with femoral fractures including subtrochanteric, intertrochanteric, comminuted, segmental, proximal/distal fractures, fractures with bone loss, and nonunions.

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.

Predicate Devices

• M/DN Intramedullary Fixation System (K965098)

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

32367
page 1 of 2

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen H. McKelvey<br>Manager, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | July 31, 2003 |
| Trade Name: | <i>ITST</i> ™ Intertrochanteric Subtrochanteric<br>Intramedullary Femoral Nail |
| Common Name: | Intramedullary Nail |
| Classification Name<br>and Reference: | Intramedullary Fixation Rod<br>21 CFR § 888.3020 |
| Predicate Device: | M/DN Intramedullary Fixation System,<br>manufactured by Zimmer, K965098, cleared<br>February 28, 1997. |
| Device Description: | The <i>ITST</i> is used to provide reduction and internal<br>fracture fixation of the femoral head and neck and<br>has an intramedullary nail that is curved and tapered<br>anatomically to accommodate the curvature of the<br>intramedullary canal. |
| Intended Use: | The <i>ITST</i> Intramedullary Nail is indicated for use in<br>a variety of femoral fractures, such as:<br>• Subtrochanteric Fractures<br>• Intertrochanteric Fractures<br>• Comminuted Fractures<br>• Segmental Fractures<br>• Fractures with Bone Loss<br>• Proximal and Distal Fractures<br>• Nonunions |

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## Comparison to Predicate Device:

Except for modifications to facilitate easier insertion, accommodate a larger lag screw and the addition of sliding and locking nail caps, ITST components are identical to the predicate device. The modifications do not change the intended use or the fundamental scientific technology. The device is packaged and sterilized using the same materials and processes.

Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

Performance testing completed as part of the design assurance procedure demonstrated that this device is safe and effective and substantially equivalent to the predicate device.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2003

Mr. Stephen H. McKelvey Manager, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708

Re: K032367

Trade/Device Name: ITST Intertrochanteric Subtrochanteric Intramedullary Femoral Nail Regulation Numbers: 21 CFR 888.3020 Regulation Names: Intramedullary fixation rod Regulatory Class: II Product Codes: HSB Dated: July 31, 2003 Received: August 1, 2003

Dear Mr. McKelvey:

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 - Mr. Stephen H. McKelvey

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/dsma/dsmamain.html

Sincerely yours,

Ulan Witt

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

KO 32367

Page I of I

510(k) Number (if known):

Device Name:

ITST" Intertrochanteric Subtrochanteric Intramedullary Femoral Nail

Indications for Use:

The ITST Intramedullary Nail is indicated for use in a variety of femoral fractures, such as:

- Subtrochanteric Fractures .
- Intertrochanteric Fractures .
- Comminuted Fractures ●
- Segmental Fractures ●
- Fractures with Bone Loss .
- Proximal and Distal Fractures .
- Nonunions ●

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Concurrence of CDRH, Office of Deyice Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number_k032367

OR

Prescription Use
(Per 21 CFR 801.109)

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Over-The-Counter Use (Optional Format 1-2-96)