GAMMA 3 NAIL SYSTEM

K032244 · Howmedica Osteonics Corp. · HSB · Aug 8, 2003 · Orthopedic

Device Facts

• Record ID: K032244
• Device Name: GAMMA 3 NAIL SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: HSB · Orthopedic
• Decision Date: Aug 8, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The product is intended for use in stabilizing various types of intertrochanteric fractures of the femur.

Device Story

Gamma 3 Nail System is an intramedullary fixation device; used for stabilization of intertrochanteric femur fractures. System includes trochanteric nails, lag screws, locking screws, and end caps. Device functions as a mechanical implant to provide structural support to fractured bone. Operated by orthopedic surgeons in clinical/surgical settings. Design is a line extension of Trochanteric Dyax and Gamma Nail systems, incorporating material and design modifications. Provides mechanical stability to fracture site to facilitate healing.

Clinical Evidence

Bench testing only; no clinical data provided. Mechanical testing demonstrated comparable mechanical properties to predicate components.

Technological Characteristics

Intramedullary fixation rod; metallic construction (implied by orthopedic nail classification); includes lag screws, locking screws, and end caps. Mechanical design based on existing Trochanteric Dyax and Gamma Nail systems.

Indications for Use

Indicated for patients requiring stabilization of intertrochanteric fractures of the femur.

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

• Trochanteric Dyax Nail System
• Gamma Nail System

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "HUMAN SERVICES - USA" are arranged in a circular pattern above the eagle. The words "DEPARTMENT OF" are arranged in a circular pattern below the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 2 8 2005

Ms. Vivian Kelly Regulatory Affairs Consultant Howmedica Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677

Re: K032244

Trade/Device Name: Gamma 3 Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: July 16,2003 Received: July 22,2003

Dear Ms. Kelly:

This letter corrects our substantially equivalent letter of August 8, 2003 regarding the Regulation Number, Regulation Name and Product Code of the above device. The correct information is listed above.

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 (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 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

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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.

This letter will allow you to continue 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,

Stipk Rurla

Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Nurnbcr (if known): K O 322

Device Name: Gamma 3 Nail System

Indications For Use:

The intended use of the subject Trochanteric Gamma 3 Nail is identical to that of the predicate Trochanteric Dyax 8 and Gamma® Nails. The product is intended for use in stabilizing various types of intertrochanteric fractures of the femur.

Muriam C. Provost

Division Sign (Division of General, Restorative and Neurological Devices

-K632244 510(k) Number—

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use -

OR

Over-The-Counter Use -

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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Special 510(k) Premarket Notification

## AUG - 8 2003 Summary of Safety and Effectiveness

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## Line Extension to the Trochanteric Dyax® & Gamma® Nail Systems

### Submission Information

| Name and Address of the Sponsor<br>of the 510(k) Submission: | Howmedica Osteonics Corp<br>59 Route 17<br>Allendale, NJ 07401-1677 |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Contact Person: | Vivian Kelly<br>Regulatory Affairs Consultant<br>Phone: [phone]<br>Fax: [phone] |

Date of Summary Preparation: July 16, 2003

#### Device Identification

| Proprietary Name: | Gamma 3 Nail System |
|------------------------------------|-----------------------------------------------|
| Common Name: | Intramedullary Nail |
| Classification Name and Reference: | Intramedullary Fixation Rod, 21 CFR §888.3020 |

This Special 510(k) submission is a line extension to the Trochanteric Dyax® and Gamma® Nail Systems. This line extension is intended to address a material modification and design modifications to the predicate Trochanteric Dyax® and Gamma® Nail Systems. Both the subject and predicate systems offer trochanteric nails, and offer various accessories such as lag screws, locking screws, and end caps.

The intended use of the subject device is identical to that of the predicate Trochanteric Dyax Nails. The device is intended for use in stabilizing various types of intertrochanteric fractures of the femur. The Trochanteric Gamma 3 Nail in the Gamma 3 Nail System also has the same basic design concepts as the currently available Trochanteric Dyax and Gamma® Nail Systems. Mechanical testing demonstrated comparable mechanical properties to the predicate components.