The DePuy Ceramic Femoral Head is indicated for use as the femoral head component in total hip arthroplasty procedures. Total hip arthroplasty is intended to provide increased patient mobility and to reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.

Device Description

The DePuy Ceramic Femoral Head is composed of an alumina composite material and is available in a 36mm head diameter with a +12-offset option. The internal bore of the ceramic femoral head, which is designed to interlock with the external taper on the femoral hip stem, is available in a 12/14 Articul/eze taper option. The ceramic head is designed to mate with a corresponding DePuy femoral hip stem and provide the femoral articular surface of a total hip replacement.

AI/ML Overview

The DePuy Ceramic Femoral Head is a ceramic femoral ball prosthesis, intended for use as the femoral head component in total hip arthroplasty procedures.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from predicate)	Reported Device Performance (DePuy Ceramic Femoral Head)
Design	Similar to predicate device (K031803)
Material Composition	Same as predicate device (K031803)
Sterilization Methods	Same as predicate device (K031803)
Packaging Methods	Same as predicate device (K031803)
Intended Use/Indications for Use	Same as predicate device (K031803)
Labels	Similar to predicate device (K031803)

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not describe a specific clinical test set or study for the DePuy Ceramic Femoral Head. Instead, the basis for substantial equivalence is primarily a comparison to a previously cleared predicate device (DePuy Ceramic Femoral Heads, K031803).

Therefore, there is no information on:

Sample size used for a test set.
Data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Since no specific test set or clinical study for this particular device is described as part of the 510(k) submission, there is no information regarding experts used to establish a "ground truth." The acceptance is based on substantial equivalence to a predicate device.

4. Adjudication Method for the Test Set

As there is no described test set or clinical study for the DePuy Ceramic Femoral Head in this submission, there is no information on an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in the provided document. The submission relies on substantial equivalence to a predicate device, not on demonstrating improved human reader performance with AI assistance (which is not applicable here as this is a physical medical device, not an AI-based diagnostic tool).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is a physical medical device (ceramic femoral head), not an algorithm or AI system. Therefore, a "standalone algorithm performance" study is not applicable and was not conducted or described.

7. Type of Ground Truth Used

The "ground truth" for this device's acceptance is the established safety and effectiveness of the legally marketed predicate device (K031803). The manufacturer asserts that the new device is substantially equivalent to this predicate based on core characteristics.

8. Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning models. Since this is a physical medical device and its clearance is based on substantial equivalence to a predicate, there is no training set in the context of an algorithm.

9. How the Ground Truth for the Training Set Was Established

As explained above, the concept of a "training set" with associated ground truth in the context of an algorithm is not applicable to this device's submission. The "ground truth" for acceptance is the predicate device's clearance.

Summary

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K040644
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NAME OF FIRM:	DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, IN 46581-0988
510(k) CONTACT:	Rebecca L. Lennard Project Engineer
TRADE NAME:	DePuy Ceramic Femoral Head
COMMON NAME:	Ceramic Femoral Ball Prosthesis
CLASSIFICATION:	888.3353: Hip joint femoral metal/ceramic/polymer, semi-constrained cemented or nonporous, uncemented prosthesis; Class II
DEVICE PRODUCT CODE:	87 LZO
SUBSTANTIALLY EQUIVALENT DEVICE:	DePuy Ceramic Femoral Heads, K031803

DEVICE DESCRIPTION AND INTENDED USE:

The ceramic head is designed to mate with a corresponding DePuy femoral hip stem and provide the femoral articular surface of a total hip replacement.

INDICATIONS FOR USE:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid arthritis, or congenital hip dysplasia.
1. Avascular necrosis of the femoral head.
1. Acute traumatic fracture of the femoral head or neck.
1. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
1. Certain cases of ankylosis.

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BASIS OF SUBSTANTIAL EQUIVALENCE:

DePuy considers the Ceramic Femoral Head to be substantially equivalent to the DePuy Ceramic Femoral Heads submitted in K031803 based on similarities in design, same material composition, same sterilization and packaging methods, same intended use/indications for use, and similar labels.

K040644
page 2 of 2

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 8 2004

Ms. Rebecca L. Lennard Project Engineer DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K040644

Trade/Device Name: DePuy Ceramic Femoral Head Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO Dated: March 10, 2004 Received: March 11, 2004

Dear Ms. Lennard:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 systems (QS) 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. Rebecca L. Lennard

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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark H. Millman

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

510(k) Number (if known): _ KOHO6 H4 Device Name: DePuy Ceramic Femoral Head

Indications for Use:

The DePuy Ceramic Femoral Head is indicated for use as the femoral head component in total hip arthroplasty procedures.

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid arthritis, or congenital hip dysplasia.
1. Avascular necrosis of the femoral head.
1. Acute traumatic fracture of the femoral head or neck.
1. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
1. Certain cases of ankylosis.

Prescription Use (Part 21 CFR 801 Subpart D)	X	AND/OR	Over-The-Counter Use (21 CFR 807 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

(Posted November 13, 2003)

510(k) Number	K040644
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Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.