PRESS-FIT HEAD RESURFACING DEVICE

• K Number: K023188
• Device Name: PRESS-FIT HEAD RESURFACING DEVICE
• Manufacturer: BIOMET ORTHOPEDICS, INC.
• Date Cleared: 2002-12-11 ( 78 days)
• Product Code: KXA
• Regulation Number: 888.3400
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K021799 , K811008 , K962514 , K811718
• Predicate For: K043542 , K071053 , K082673

Intended Use

Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis, and rheumatoid arthritis. The device is a single use implant intended for press-fit application.

Device Description

The Press-Fit Head Resurfacing device is designed to replace the outer surface of the femoral head while preserving as much natural bone as possible. The device retains the diameter of the natural femoral head and articulates aqainst the natural acetabulum (hemi-hip). The device is manufactured from cobalt alloy (Co-Cr-Mo) conforming to ASTM F-75. It has a highly polished outer surface and a titanium plasma spray coated inner surface. A central post is provided for stabilization. The device is available in diameters of 38mm to 60mm, in one-millimeter increments.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, the "Press-Fit Head Resurfacing Device." It does not present any clinical study data or acceptance criteria related to device performance.

Based on the content of the document, the following observations can be made relevant to your request:

1. Table of acceptance criteria and reported device performance:

   • Not Applicable: The document explicitly states "Non-Clinical and Clinical Testing: None provided." This indicates that no performance data from such studies, nor specific acceptance criteria, are included or were required for this 510(k) submission.

2. Sample size used for the test set and the data provenance:

   • Not Applicable: As no clinical or non-clinical testing data is provided, there is no test set or associated sample size discussed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable: No clinical or non-clinical testing was provided, so no ground truth establishment by experts is mentioned.

4. Adjudication method for the test set:

   • Not Applicable: No clinical or non-clinical testing was provided, so no adjudication method is mentioned.

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:

   • Not Applicable: This device is a physical implant (a hemi-hip prosthesis), not an AI-powered diagnostic or imaging device. Therefore, an MRMC study or AI assistance is not relevant to its evaluation.

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

   • Not Applicable: This device is a physical implant, not an algorithm.

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

   • Not Applicable: No clinical or non-clinical testing was provided, so no ground truth is discussed.

8. The sample size for the training set:

   • Not Applicable: There is no mention of a training set as no machine learning or AI component is involved.

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

   • Not Applicable: No training set or associated ground truth establishment is mentioned.

Summary of Safety and Effectiveness from the Document:

The document states one "Summary of Safety and Effectiveness." The basis for substantial equivalence is primarily on material and design similarities, not on performance data from primary studies.

"The materials, surface finishes and processing of the Press-Fit Head Resurfacing Device are similar to the predicate device."

This 510(k) submission relies on demonstrating substantial equivalence to already legally marketed devices based on technological characteristics and intended use, rather than presenting novel clinical performance data. The FDA's decision to clear the device (K023188) was based on this substantial equivalence to predicate devices (K021799, K811008, K962514, K811718), and not on a new study demonstrating its performance against specific acceptance criteria.

Summary

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KQ2388
page 1 of 1

Summary of Safety and Effectiveness

Applicant/Sponsor:	Biomet Orthopedics, Inc.
	P.O. Box 587
	Warsaw, Indiana 46581-0587

DEC 1 1 2002

• Contact Person: Patricia Sandborn Beres Senior Requlatory Specialist Phone: [phone] Fax: [phone]
  Trade Name: Press-Fit Head Resurfacing Device

Common Name: Hemi-hip

Classification Name: Hip joint femoral (hemi-hip) metallic resurfacinq prosthesis (21 CFR 888.3400)

Legally Marketed Device to which Substantial Equivalence is claimed: Cemented Femoral Head Resurfacing Device (K021799), Conserve Head (K811008), TARA Head (K962514), Surface Replacement Hip Prostheses (K811718)

Device Description: The Press-Fit Head Resurfacing device is designed to replace the outer surface of the femoral head while preserving as much natural bone as possible. The device retains the diameter of the natural femoral head and articulates aqainst the natural acetabulum (hemi-hip).

The device is manufactured from cobalt alloy (Co-Cr-Mo) conforming to ASTM F-75. It has a highly polished outer surface and a titanium plasma spray coated inner surface. A central post is provided for stabilization. The device is available in diameters of 38mm to 60mm, in one-millimeter increments.

Intended Use: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis and rheumatoid arthritis. The device is a single use implant intended for press-fit application.

Summary of Technologies: The materials, surface finishes and processing of the Press-Fit Head Resurfacing Device are similar to the predicate device.

Non-Clinical and Clinical Testing: None provided

MAILING ADDRESS Warsaw, IN 46581-0587 SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 574.267.6639

FAX [phone]

E-MAIL
[e-mail]

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 11 2002.

Ms. Patricia Sandborn Beres Senior Regulatory Affairs Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K023188

Trade Name: Press-Fit Head Resurfacing Device Regulation Number: 21 CFR 888.3400 Regulation Name: Hip joint femoral (hemi-hip) metallic resurfacing prosthesis Regulatory Class: II Product Code: KXA Dated: September 23, 2002 Received: September 24, 2002

Dear Ms. Sandborn Beres:

We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality svstems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Patricia Sandborn Beres

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on 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 premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

l Math A. Melleman

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): KO3 3183

Press-Fit Head Resurfacing Device Device Name:

Indications For Use:

Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis, and rheumatoid arthritis.

The device is a single use implant intended for press-fit application.

for Mark N. Mulkerson

(Division Si Division of General, Fir - : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : and Neurological Dev. 023188 510(k) Number _

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

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Regulation Number and Section

§ 888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metallic resurfacing prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral resurfacing component made of alloys, such as cobalt-chromium-molybdenum.(b)
Classification. Class II.