ZETA MULTIZONE LOCKING NAIL SYSTEM

K984305 · Howmedica, Inc. · HSB · Feb 1, 1999 · Orthopedic

Device Facts

• Record ID: K984305
• Device Name: ZETA MULTIZONE LOCKING NAIL SYSTEM
• Applicant: Howmedica, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Feb 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Zeta MultiZone Humeral Locking Nail System is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the humerus. The nails are inserted using an opened or closed technique and can be statically or dynamically locked.

Device Story

Zeta MultiZone Humeral Locking Nail System provides temporary stabilization for humeral fractures, malunions, and nonunions. System comprises round intramedullary nails, cross-locking screws, and end caps. Nails feature proximal and distal holes for static or dynamic locking. Device is implanted by surgeons using open or closed surgical techniques. System serves as a line extension to existing intramedullary rod systems, utilizing established orthopedic fixation principles to stabilize bone segments during healing. Benefits include mechanical support for fractured humerus to facilitate bone union.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Intramedullary fixation rod system. Materials: titanium alloy or stainless steel. Components: round nails, cross-locking screws, end caps. Mechanical fixation via intramedullary insertion with static or dynamic locking capability.

Indications for Use

Indicated for temporary stabilization of humeral fractures, malunions, and nonunions in patients requiring intramedullary fixation. No specific age or gender contraindications stated.

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

• Alta IM Rod System
• Locking Nail System
• Gamma Locking Nail System

Submission Summary (Full Text)

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FEB | 1 1999

K9841305

## 510(k) Summary

Proprietary Name: Common Name: Classification Name & Reference: Proposed Regulatory Class: Device Product Code:

Zeta MultiZone Locking Nail System IM Rod Intramedullary Fixation Rod 21 CFR 888.3020 1 87 HSB

For information contact:

Joseph Volpe Senior Regulatory Affairs Specialist Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: [phone] Fax: [phone]

Date Prepared: December 1, 1998

The Zeta MultiZone Locking Nail System consists of a family of round nails used for intramedullary nailing of femoral, tibial and humeral fractures. This line extension is to include a humeral nail, cross-locking screws and end caps. The humeral nails are available in varying diameters and lengths and have proximal and distal holes for cross-locking. The nails and additional components are fabricated from either titanium alloy or stainless steel.

The Zeta MultiZone Humeral Locking Nail System is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the humerus. The nails are inserted using an opened or closed technique and can be statically or dynamically locked.

The substantial equivalence of the humeral nail is based on an equivalence in intended use, materials, designs and operational principles to Howmedica's Alta IM Rod System, Howmedica's Locking Nail System and Gamma Locking Nail System.

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Public Health Service

Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its body and wings. The bird is facing left. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1999

Mr. John F. Dichiara Director of Regulatory Affairs and Public Policy Howmedica Inc. Pfizer Medical Technology Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

K984305 Re: Zeta Multizone Humeral Locking Nail System Regulatory Class: II Product Code: HSB Dated: December 1, 1998 Received: December 2, 1998

Dear Mr. Dichiara:

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 The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಕ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 regulation may result in regulatory 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 requlations.

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## Paqe 2 - Mr. John F. Dichiara

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 requlation (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 gener 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,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K98

K984305

Device Name: Zeta MultiZone Humeral Locking Nail System

Indications for Use:

The Zeta MultiZone Humeral Locking Nail System is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the humerus. The nails are inserted using an opened or closed technique and can be statically or dynamically locked.

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Concurrence of CDRH, Office of Device Evaluation (ODE) OR Prescription Use Over-The-Counter Use_ (Per 21 CFR 801.109) (Optional Format 1-2-96)

tiptes for MW

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Division of General Restorative Devices Konus

Division of General Restarative Dev 510(k) Numl