Femoral head/neck fractures or non-unions .
Aseptic necrosis of the femoral head; .
Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular . involvement or distortion;
Pathological conditions or age considerations which indicate a more conservative . I amongiour conditions of up voidance of the use of bone cement in the acetabulum;
Salvage of failed total hip arthroplasty. .

Indications for use as part of a Total Hip Replacement include:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis;
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other ● procedure;
Procedury, . are less likely to achieve satisfactory results.

Device Description

This Special 510(k) submission is intended to address a design modification to the Omnifit EON Femoral Stems. This modification will create the new subject device, hereby referred to as the Super EON Plus femoral stems to expand the product line. The intended use, manufacturing methods, materials, packaging and sterilization of the subject device are identical to those of predicate devices. The subject device is fabricated from forged cobalt chromium alloy conforming to ASTM F 799. The Super EON Plus femoral stems are available in 127 degree and 132 degree neck angles and range in size from size #4 through size #10.

AI/ML Overview

The provided text describes a design modification to the Omnifit EON Femoral Stems, creating the new Super EON Plus Femoral Stems. The core of the information addresses the substantial equivalence determination for this new device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical (Fatigue) Strength Comparable to Predicate	Fatigue testing of the subject Super EON Plus femoral stems demonstrated that the body and neck strength are comparable to the body and neck strength of the predicate Omnifit EON Femoral Stems.
Intended Use Identical to Predicate	Like the predicate devices, the subject devices are intended for primary and revision total or hemi-hip arthroplasty. These devices are intended for use in cemented applications.
Manufacturing Methods Identical to Predicate	The manufacturing methods of the subject device are identical to those of predicate devices.
Materials Identical to Predicate	The materials of the subject device are identical to those of predicate devices. (Subject device fabricated from forged cobalt chromium alloy conforming to ASTM F 799).
Packaging Identical to Predicate	The packaging of the subject device is identical to those of predicate devices.
Sterilization Identical to Predicate	The sterilization of the subject device is identical to those of predicate devices.

2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the fatigue testing. It also does not explicitly state the provenance of the data (e.g., country of origin, retrospective or prospective). However, given it's a 510(k) submission to the FDA, the testing would have been conducted to US regulatory standards. The testing appears to be prospective as it's specifically for the new device and its predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable in this context. The study described is a mechanical fatigue test of a medical device (femoral stem). It does not involve human subjects, image interpretation, or diagnostic decision-making, where "ground truth" would typically be established by human experts. The "ground truth" here is the physical performance of the device against established engineering standards and comparison with the predicate device.

4. Adjudication Method for the Test Set
This question is not applicable. As stated in point 3, this is a mechanical test, not one involving human decision-making or disagreement that would require an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This study is a mechanical performance comparison of a medical implant, not an AI or diagnostic imaging device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, this is not applicable. The device is an artificial hip component, not an algorithm or AI system.

7. The type of ground truth used
The "ground truth" used for this study is physical measurement and engineering standards conformance. The performance of the Super EON Plus femoral stems was compared to that of the predicate Omnifit EON Femoral Stems and likely against relevant ASTM standards for fatigue strength of implants.

8. The sample size for the training set
This question is not applicable. There is no "training set" as this is not an AI or machine learning study. It is a physical device safety and performance study.

9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.

Summary

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	SUBJECT DEVICE	PREDICATE DEVICE
Proprietary Name:	Super EON Plus Femoral Stems	Omnifit EON Femoral Stems
Common Name:	Artificial Hip Component	Artificial Hip Component
Classification Name andReference:	21 CFR §888.3350Hip Joint Metal/ Polymer Semi-constrained Cemented Prosthesis	21 CFR §888.3350Hip Joint Metal/ Polymer Semi-constrained Cemented Prosthesis
Proposed Regulatory Class:	II	II
Device Product Code:	(87) JDI	(87) JDI
For Information contact:	Jennifer A. Daudelin. Regulatory AffairsHowmedica Osteonics Corp.59 Route 17Allendale, NJ 07401-1677(201) 831-5379Fax: (201) 760-8435Email: jdaudelin@howost.com

Special 510(k) Summary – SUPER EON PLUS FEMORAL STEMS

Device Description

Predicate Device

The predicate Omnifit EON femoral stems were found substantially equivalent via the 510(k) process in K983226.

{1}------------------------------------------------

Fatigue testing of the subject Super EON Plus femoral stems demonstrated that the body and neck strength are comparable to the body and neck strength of the predicate Omnifit EON Femoral Stems.

Intended Use

Like the predicate devices, the subject devices are intended for primary and revision total or hemi-hip arthroplasty. These devices are intended for use in cemented applications.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing service to the individual and the family. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the left side of the logo.

Public Health Service

APR 26.2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jennifer A. Daudelin Regulatory Affairs Associate Howmedica Osteonics Corporation 59 Route 17 Allendale. New Jersey 07401-1677

Re: K020989

Trade Name: Super EON Plus Femoral Stem Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal / Polymer / Semi-Constrained / Cemented Prosthesis Regulatory Class: II Product Code: JDI Dated: March 26, 2002 Received: March 27, 2002

Dear Ms. Daudelin:

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.

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. A 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 regulations.

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Page 2 - Ms. Jennifer A. Daudelin

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 (301) 594-4659. Additionally, for questions on 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 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 (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

b. Mark N. Milkman

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

Enclosure

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Indications for Use

page lot

510(k) Number (if known):

Device Name: Super EON Plus Femoral Stems

Indications for Use:

Indications for use as a Bipolar or Hemi-Hip Replacement:

Femoral head/neck fractures or non-unions .
Aseptic necrosis of the femoral head; .
Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular . involvement or distortion;
Pathological conditions or age considerations which indicate a more conservative . I amongiour conditions of up voidance of the use of bone cement in the acetabulum;
Salvage of failed total hip arthroplasty. .

Indications for use as part of a Total Hip Replacement include:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis;
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other ● procedure;
Procedury, . are less likely to achieve satisfactory results.

Mark n millerson

(Division Sign-Of (Division of General, Restorative and Neurological Devices

(PLEASE DO NOT WRITE BELOW THIS LINE - CONFINE WANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
X
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

N/A