EPI-UNION PLATING SYSTEM

K974289 · Howmedica, Inc. · HRS · Feb 12, 1998 · Orthopedic

Device Facts

• Record ID: K974289
• Device Name: EPI-UNION PLATING SYSTEM
• Applicant: Howmedica, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Feb 12, 1998
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EPI-Union Plating System is intended for use in the internal fixation of long bone fractures and long bone reconstruction.

Device Story

Epi-Union Plating System consists of orthopedic plates and screws for internal fixation of long bone fractures and reconstruction. System includes tibial, fibular, calcaneal, humeral, and radial plates; precontoured to anatomical profiles. Screws include cancellous and cortical types, 6mm and 8mm head diameters, 3.5mm to 6.5mm thread diameters; available in self-tapping, non-self-tapping, fully threaded, and partially threaded designs. Used by orthopedic surgeons in clinical/surgical settings. Device provides mechanical stabilization of bone segments to facilitate healing. Not for use in spinal pedicular fixation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System comprises metallic plates and screws for bone fixation. Features include precontoured plate geometries and varied screw thread/head configurations. Mechanical fixation principle. No software or electronic components.

Indications for Use

Indicated for internal fixation of long bone fractures and long bone reconstruction in patients requiring orthopedic surgical intervention. Contraindicated for pedicular screw fixation or attachment to the cervical, thoracic, or lumbar vertebral column.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Synthes' ASIF® Implants
• Dupont Distal Humeral Plate System
• BG Compression System

Submission Summary (Full Text)

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510(k) Summary

FEB | 2 |998

K974289

Device:

Epi-Union Plating System

For information contact:

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

The Epi-Union Plating System consists of a series of plates and screws for the internal fixation of long bone fractures and long bone reconstruction. The plates are available in different styles and configurations to fit various anatomical sites. Each plate has holes for screw fixation. The different styles of plates are precontoured to fit the anatomical profile of each specific site. The system includes tibial plates, fibular plates, calcaneal plates, humeral plates, and radial plates.

The system includes cancellous and cortical screws with head diameters of 6mm and 8mm. The screws are available in thread diameters ranging from 3.5mm to 6.5mm in varying lengths. Different styles include self-tapping, non-self-tapping, fully threaded, and partially threaded screw designs. The plates can also be used with standard cortical or cancellous bone screws that are commercially distributed.

The substantial equivalence of these components is based on an equivalence in intended use, materials, design, and operational principles to other predicate devices used for internal fixation of long bones. These devices include Synthes' ASIF® Implants, the Dupont Distal Humeral Plate System and BG Compression System distributed by Howmedica Inc.

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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 heads, representing the department's mission to protect the health of all Americans. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is simple and recognizable, and it is used on a variety of government documents and websites.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 1998

Ms. Vivian Kelly Manager, Regulatory Affairs Howmedica, Inc. 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

Re: K974289 EPI-UNION Plating System Regulatory Class: II Product Code: HRS and HWC November 14, 1997 Dated: Received: November 14, 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 registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Note that labeling or otherwise promoting a device for pedicular screw fixation/attachment would cause the device to be adulterated under 501(f)(1) of -------This device, if intended for use in pedicular screw the Act. fixation/attachment, would be found not substantially equivalent and would be a class III device under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to Accordinqly: marketinq.

- The package insert must prominently state that the device 1. is intended for the specific use(s) described in the enclosure only; and

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Page 2 - Ms. Vivian Kelly

- You may not label or in any way promote this device for 2. pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. If this device is a screw with outer diameters of 3 mm - 10 mm and overall lengths of 10 mm - 75 mm inclusively, the package insert must include the following statement, This device is not approved for screw "WARNING: attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine." Any pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under Part 812. All users of the device for pedicular 21 CFR, screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conduct of the investigation.
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. તે 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 In addition, FDA may publish further announcements action. 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.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.

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Page 3 - Ms. Vivian Kelly

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 Additionally, for questions on Compliance at [phone]. 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 --------Other general premarket notification" (21 CFR 807.97). 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,

[signature]

Cellia 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): K974289

Device Name: EPI-UNION™ PLATING SYSTEM

Indications for Use:

The EPI-Union Plating System is intended for use in the internal fixation of long bone fractures and long bone reconstruction.

Prescription Use
(Per 21 CFR 801.109)

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(Divisio Divisio 510(k) Nur