The subject Exeter V40™ Hip System components are intended for use in total hip replacement. They are intended for cemented use only. The subject components are intended for use with any Howmedica Osteonics Corp. acetabular component featuring a polyethylene bearing surface.

Indications:

Noninflammatory joint disease including osteoarthritis and avascular necrosis, .
Rheumatoid arthritis, .
Correction of functional deformity, .
Revision procedures where other treatments or devices have failed, .
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Device Description

This Special 510(k) covers a modified Exeter Hip System which differs from the existing, predicate Exeter Hip System primarily in that it features a different trunnion known as the V40™ Taper. In addition to the change in Exeter Hip Stems and Heads from the predicate trunnion design to the newer V40™ Taper, this submission includes some additional stem and head sizes, the addition of an insertion dimple on the stems, reduction in stem neck diameter, and a new wingless version of the stem centralizer component.

AI/ML Overview

The original document is a 510(k) Premarket Notification for a medical device: the Modified Exeter Hip System with V40™ Taper. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for demonstrating novel clinical efficacy through extensive clinical trials. Therefore, much of the requested information regarding clinical study design (sample sizes, expert qualifications, adjudication, MRMC studies, training set details) is not applicable or available in this type of regulatory submission. The focus is on engineering and mechanical testing to ensure safety and function.

Here's the information extracted from the provided text, with clarifications where the requested detail is not present in a 510(k) submission:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Standard Adherence)	Reported Device Performance
Successfully endure testing in accordance with ISO 7206-4	Successfully endured testing
Successfully endure testing in accordance with ISO 7206-6	Successfully endured testing
Suitability for use with subject hip stems (for Zirconia V40™ Femoral Heads)	Demonstrated suitability

2. 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 specified in the document. This typically refers to the number of devices or components tested, which would be governed by the specific ISO standards.
Data Provenance: Not specified. This documentation relates to mechanical testing, not clinical data provenance. Given the nature of a 510(k) and the testing standards, this would be laboratory testing.

3. 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. For mechanical testing of medical devices, "ground truth" as it pertains to expert interpretation of clinical data is not a concept. The "ground truth" is adherence to the mechanical performance specifications set by the ISO standards. The evaluation is against these predefined engineering criteria, not expert consensus on medical images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods are relevant for clinical trials where there's variability in interpretation (e.g., image reading). Mechanical testing relies on objective measurements against pre-defined engineering standards; therefore, an adjudication method for test data is not relevant here.

5. 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

No. This is a mechanical device, not an AI-powered diagnostic tool. MRMC studies are not relevant for this type of device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This is a mechanical hip implant, not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Mechanical Standards: The "ground truth" for this device's performance testing is adherence to the specifications and performance requirements outlined in the referenced ISO standards (ISO 7206-4 and 7206-6). For the Zirconia V40™ Femoral Heads, the 'ground truth' was their "suitability for use" with the subject hip stems, implying compatibility and performance within acceptable limits as determined by testing.

8. The sample size for the training set

Not Applicable. This is a mechanical hip implant, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

Not Applicable. (See #8)

Summary

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JUN 1 5 2001

K011623

Modified Exeter Hip System with V40™ Taper

Special 510(k) Premarket Notification

Special 510(k) Summary - Modified Exeter Hip System with V40™ Taper

Proprietary Name: Common Name : Classification Name and Reference:

Proposed Regulatory Class : Device Product Code : For Information contact:

Exeter Hip System with V40TM Taper Artificial Hip System Prosthesis. Hip. Semi-Constrained. Metal/Polymer/Metal, Cemented, 21 CFR $888.3350 Class II 87 JDI Nancy J. Rieder Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401 Phone: (201) 934-4364 Fax: (201) 760-8435

Description/Technologicol Comparison

Intended Use

Indications:

Noninflammatory joint disease including osteoarthritis and avascular necrosis, .
Rheumatoid arthritis, .

Page 3

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Modified Exeter Hip System with V40™ Taper

Correction of functional deformity, .
Revision procedures where other treatments or devices have failed, .
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.

Testing Summary

The subject modified hip stems have successfully endured testing in accordance with ISO 7206-4 and 7206-6. Testing of commercially available Zirconia V40™ Femoral Heads demonstrated their suitability for use with the subject hip stems.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.

JUN 1 5 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Nancy J. Rieder Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re: K011623

Trade Name: Exeter Hip System with V40" Taper Regulation Number: 888.3350 Regulatory Class: II Product Code: JDI Dated: May 24, 2001 Received: May 25, 2001

Dear Ms. Rieder:

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.

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.

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Page 2 - Ms. Nancy J. Rieder

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 additionally, of 59. Additionally, for questions on the promotion and advertising of your device, (2017) 594-1639. Tradition 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 mormaton on Jour Soll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mesturth

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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510(k) Number (if known): K011623

Device Name: Modified Exeter Hip System with V40TM Taper

Indications:

Noninflammatory joint disease including osteoarthritis and avascular necrosis, .
Rheumatoid arthritis, .
Correction of functional deformity, .
Revision procedures where other treatments or devices have failed, .
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with ● head involvement that are unmanageable using other techniques.

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

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)

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K011623

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.