EXETER INTRAMEDULLARY BONE PLUG by HOWMEDICA, INC.

The Exeter II Intramedullary Bone Plug is intended to be used to restrict the migration of bone cement down the femoral canal and permit cement pressurization during total hip arthroplasty. The Exeter Intramedullary Bone Plug is intended to be used with bone cement.

Device Description

The Exeter Intramedullary Bone Plug is a molded acrylic device that is designed to be placed in the femoral canal prior to the insertion of a femoral stem. The bone plug restricts the migration of bone cement down the femoral canal and permits cement pressurization within the canal. The Bone Plug is a cone shaped device available in a range of diameters to accomodate various anatomical requirements. The distal portion of the plug is designed with circumferential ridges that create an interference fit between the plug and the femoral canal. Slots are cut into the ridge portion of the bone plug to allow the plug to compress slightly during insertion down the canal. The body of the plug contains a threaded portion for use with an insertion instrument.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called the "Exeter Intramedullary Bone Plug." The submission focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study with specific acceptance criteria and performance metrics in the way a diagnostic AI device would.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable to this type of regulatory submission. The document explicitly states: "The substantial equivalence of the Exeter Bone Plug is based on an equivalence in intended use, design, materials, operational principles, and relative indications and contraindications to the Howmedica's polyethylene Exeter Bone Plug, (K933077) and Exeter II Distal Centralizer (K974054)."

Here's an attempt to answer the questions based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present:

A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence: Equivalence in intended use, design, materials, operational principles, and relative indications and contraindications to predicate devices.	The device is described as having the "same design as the currently marketed device" and is stated to be substantially equivalent to K933077 and K974054 based on the criteria listed. No specific performance metrics (e.g., bone cement restriction percentage or pressurization values) are provided.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This submission relies on substantial equivalence to predicate devices, not new performance data from a test set.
- Data Provenance: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth assessment by experts for a test set is not described in this type of submission.
Adjudication method (e.g. 2+1, 3+1, none) 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 is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The "ground truth" in this context is the performance and safety established for the predicate devices, which is what the new device is compared to for substantial equivalence. No new ground truth data is generated for this specific submission as it relies on equivalence.
The sample size for the training set
- Not applicable. This is not a machine learning device.
How the ground truth for the training set was established
- Not applicable.

Summary

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2 1998 JUN

510(k) Summarv

K980843

Proprietary Name: Intramedullary Bone Plug, Exeter Hip System

Common Name: Cement Restrictor

Classification Name and Reference: 21 CFR 888.3350 Prosthesis, Hip, Semi-Constrained, Metal/Polymer

Proposed Requlatory Class: Class II

Device Product Code: LZN , 30I

For information contact:

Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford. NJ 07070 Telephone: (201) 507-7875 Fax: (201) 507-6870 Date Summary Prepared: 3-3-98

The Exeter Bone Plug described in this submission is the same design as the currently marketed device. The Bone Plug is a cone shaped device available in a range of diameters to accomodate various anatomical requirements. The distal portion of the plug is designed with circumferential ridges that create an interference fit between the plug and the femoral canal. Slots are cut into the ridge portion of the bone plug to allow the plug to compress slightly during insertion down the canal. The body of the plug contains a threaded portion for use with an insertion instrument.

The substantial equivalence of the Exeter Bone Plug is based on an equivalence in intended use, design, materials, operational principles, and relative indications and contraindications to the Howmedica's polyethylene Exeter Bone Plug, (K933077) and Exeter II Distal Centralizer (K974054).

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 1998

Ms. Margaret F. Crowe Group, Requlatory Affairs Manager Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

Re: K980843 Exeter Intramedullary Bone Plug Trade Name: Requlatory Class: II Product Codes: JDI and LZN Dated: March 3, 1998 Received: March 4, 1998

Dear Ms. Crowe:

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 Requlations, 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 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.

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Page 2 - Ms. Margaret F. Crowe

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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

ia M. Witten, Ph.D., M.D. Cel 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): K980843

Device Name: Exeter Intramedullary Bone Plug

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER 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)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K980843

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.