GAMMA LOCKING NAIL SYSTEM

K972813 · Howmedica Corp. · HSB · Oct 9, 1997 · Orthopedic

Device Facts

• Record ID: K972813
• Device Name: GAMMA LOCKING NAIL SYSTEM
• Applicant: Howmedica Corp.
• Product Code: HSB · Orthopedic
• Decision Date: Oct 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended for use in stabilizing various types of intertrochanteric fractures of the proximal femur.

Device Story

Gamma Locking Nail System is a line extension of previously cleared femoral nails. Device consists of femoral nails, lag screws, set screws, and cap screws used for intramedullary fixation. Intended for stabilization of intertrochanteric fractures of the proximal femur. Operates via mechanical fixation of bone fragments. Used by orthopedic surgeons in clinical/surgical settings. Provides structural support to facilitate fracture healing.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material characteristics.

Technological Characteristics

Constructed from Orthinox stainless steel. System includes femoral nails, lag screws, set screws, and cap screws. Mechanical intramedullary fixation device. No software or electronic components.

Indications for Use

Indicated for the stabilization of intertrochanteric fractures of the proximal 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

• Standard Gamma Locking Nails
• Long Gamma Locking Nails
• Omega Compression Hip Screw System

Submission Summary (Full Text)

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## 510(k) Summary

7 1813

Gamma® Locking Nail System Proprietary Name: Common Name: Femoral Nail Intramedullary Fixation Rod Classification Name & 21 CFR 888.3020 Reference: Proposed Regulatory Class: II 87HSB Device Product Code:

For information contact:

Vivian Kelly Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: [phone] Fax: [phone]

The Gamma® Locking Nail System consist of a family of femoral nails, lag screws set screws rno cap screws for intramedullary nailing of proximal femoral fractures. This line extension is a and ouplification of the currently marketed Gamma nails cleared under various 510(k) notifications. mounter, or the builter, rounder nails will retain the major design features of the previously cleared Gamma nails and will be made from Orthinox® stainless steel.

This device is intended for use in stabilizing various types of intertrochanteric fractures of the proximal femur.

The substantial equivalence of these components is based on an equivalence in intended use, materials, design, and operational principles to Howmedica's Standard and Long Gamma Locking Nails and Howmedica's Omega Compression Hip Screw System.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three overlapping, curved lines representing its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 9 1997

Ms. Vivian Kelly Manger, Requlatory Affairs Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard 07070-2584 Rutherford, New Jersey

K972813 Re: Trade Name: Gamma® Nail Line Extension Requlatory Class: II Product Code: нав Dated: July 28, 1997 Received: July 29, 1997

Dear Ms. Kelly:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 reqistration, 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 (Premarket Approval), 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 895. ಗ್ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Vivian Kelly

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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## Indications for Use

510(k) Number (if known): K97 2813

Device Name: Gamma® Nail Line Extension

Indications for Use:

This device is intended for use in stabilizing various types of intertrochanteric fractures of the proximal femur.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)
OR

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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

(Division Sign-Off) Division of General Restorative Device 510(k) Number