EPI-UNION PLATING SYSTEM by HOWMEDICA, INC.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Epi-Union Plating System." This document is a regulatory approval, not a scientific study. Therefore, it does not contain information regarding acceptance criteria, device performance metrics, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment.

A 510(k) submission primarily focuses on demonstrating "substantial equivalence" to a predicate device already legally marketed. This typically involves comparing:

Intended Use: The purpose for which the devices are used.
Technological Characteristics: Design, materials, and operational principles.
Performance Data: Often includes bench testing (mechanical, material, biocompatibility) to show that the new device performs as safely and effectively as the predicate, but usually does not involve clinical studies with human participants unless specifically requested by the FDA for novel aspects.

Given the content, I cannot fill in the requested table and study details as they are not present in this type of regulatory document.

Therefore, the response is:

This 510(k) summary does not contain the information required to describe the acceptance criteria and a study proving the device meets those criteria. The document is a regulatory approval demonstrating substantial equivalence to predicate devices, not a scientific study detailing performance metrics, sample sizes, ground truth establishment, or clinical effectiveness.

Specifically, the following information is not available in the provided text:

A table of acceptance criteria and the reported device performance: Not present. The document focuses on equivalence, not specific performance metrics against defined criteria.
Sample sized used for the test set and the data provenance: Not present. No clinical or comparative performance study with a test set is detailed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no mention of a test set with ground truth.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a plating system, not an AI or imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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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 (201) 507-7830 Fax: (201) 507-6870

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 (301) 594-4659. the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)

fucello

(Divisio Divisio 510(k) Nur

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
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.(b)
Classification. Class II.