Prosthetic replacement of the femoral head associated with a hip prosthesis having a taper compatible with the head taper, and with a prosthetic UHMWPE acetabulum having an inside diameter compatible with that of the head.

The alumina head can only be used with polyethylene inserts.

This prothesis may be used for degenerative ioint disease such as osteoarthritis and avascular necrosis, correction of functional deformity, rheumatoid arthritis, revision procedure where other devices or treatments have failed, congenital dislocation, femoral neck and trochanteric fractures, traumatic arthritis, fused diastrophic variant, slipped capital hip, epiphysis, non-union.

Device Description

Alumina heads are made of Biolox forte alumina (trademark of CERAMTEC) according to ISO 6474 standard.

Alumina heads have a 12/14 cone and are available in two diameters: 28mm and 32mm, with three offsets: -3.5; 0; +3.5.

This special 510 (k) is being submitted to propose an extension at the 10/12 cone in diameter : 32 mm with three offsets: -3.5; 0; +3.5. This heads are made in HIP Vitox® alumina (trademark of Morgan Advanced Ceramics Ltd according to ISO 6474 standard.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "ALUMINA HEADS," which are ceramic femoral heads for hip prostheses. The submission is an extension for additional cone sizes. The document outlines material characteristics and performance tests, but it does not describe an AI/device acceptance criteria study.

Therefore, many of the requested categories cannot be answered from the provided text.

Here's a breakdown of what can be answered based on the input:

1. Table of Acceptance Criteria and Reported Device Performance

The document references compliance with established standards and FDA guidelines rather than defining specific numerical acceptance criteria.

Acceptance Criteria Category	Reported Device Performance
Material Characteristics	- Compliant with FDA's "Guidance document for the preparation of premarket notifications for ceramic ball hip systems" dated January 10, 1995. - 10/12 cone alumina heads reach all requirements set up in this guidance document.
Performance - Fatigue Test	- Results in compliance with selected standard (implied, as part of overall performance claim). - All results were in compliance with the requirements set forth by the FDA.
Performance - Static Compression Test to Rupture	- Results in compliance with selected standard (implied, as part of overall performance claim). - All results were in compliance with the requirements set forth by the FDA.
Performance - Pre-loading of femoral head and extraction force measurement	- Results in compliance with selected standard (implied, as part of overall performance claim). - All results were in compliance with the requirements set forth by the FDA.

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

Not applicable. This is a medical device for orthopedic surgery, not an AI/software device. The tests performed are mechanical in nature, on the device itself, not on data.

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

Not applicable. (See #2)

4. Adjudication Method for the Test Set

Not applicable. (See #2)

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not applicable. This document describes a physical medical device (ceramic femoral head), not an AI algorithm or diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. (See #5)

7. The Type of Ground Truth Used

Not applicable. The "ground truth" for this device's performance is established by its compliance with predefined mechanical performance standards (e.g., ISO 6474) and FDA guidance documents for ceramic hip systems.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary

{0}------------------------------------------------

MAY 1 2005

K050556 (pg 1 of 2)

510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS ALUMINA HEADS

Fournitures Hospitalières Industrie SPONSOR IDENTIFICATION: 6 Rue Nobel, Z.I. de Kernevez 29000 QUIMPER - FRANCE Tel: (33) 2.98.55.68.95 Fax: (33) 2.98.53.42.13

ESTABLISHMENT REGISTRATION NUMBER: 3003898228

OFFICIAL CONTACT PERSON: Christine QUENDEZ
Regulatory Affairs Manager
E-mail: fhi.rd@wanadoo.fr

DATE PREPARED:

February 4th, 2005

DEVICE TRADE NAME:	ALUMINA HEADS
DEVICE COMMON NAME:	Ceramic Femoral Head
CLASSIFICATION NAME:	Hip joint metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis
REGULATORY CLASS:	Class II
DEVICE PRODUCT CODE:	87 LZO
PANEL CODE:	21 CFR 888.3353

DEVICE DESCRIPTION:

Alumina heads are made of Biolox forte alumina (trademark of CERAMTEC) according to ISO 6474 standard.

Alumina heads have a 12/14 cone and are available in two diameters: 28mm and 32mm, with three offsets: -3.5; 0; +3.5.

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

$$
\begin{pmatrix}
\mathfrak{L}{\mathfrak{L}}\mathfrak{L}{\mathfrak{L}}\mathfrak{L}{\mathfrak{L}} \
\mathfrak{L}{\mathfrak{L}}\mathfrak{L}{\mathfrak{L}}\mathfrak{L}{\mathfrak{L}}
\end{pmatrix}
$$

INDICATIONS FOR USE:

PREDICATE DEVICES:

The proposed Alumina heads are now provided with a 10/12 cone. They have exactly the same intented use and same design as the predicate devices.

Regarding the material, numerous alumina heads are made in alumina in accordance ISO 6474 standard.

And regarding the design, numerous femoral heads made in 10/12 cone with a diameter 32.

So, we have selected two predicate devices based upon intended uses, material used in device manufacturing and design features.

These predicate devices are:

Alumina Head (K042035), F.H. Industrie l
ESOP® Co-Cr femoral head (K021109), F.H. Industrie -

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

Our alumina heads have the same intended use and substantial similar indications for use as the predicate devices. They are all made of the same material (Alumina), are available in similar diameters and lengths, with similar designs (10/12 cone).

… そ

Performance tests were performed. Our proposed devices and the predicate devices were found to have results in compliance with the selected standard.

MATERIAL CHARACTERISTICS:

We have followed the FDA's guideline: "Guidance document for the preparation of premarket notifications for ceramic ball hip systems" dated January 10, 1995 to compare if our material characteristics were in conformity with the FDA requirements. Our 10/12 cone alumina heads reach all the requirements set up in this guidance document.

PERFORMANCES:

To evaluate the safety and effectiveness of our Alumina heads, we have made three series of tests:

Fatigue test and static compression test to rupture in the first series -
Test of static compression to rupture in the second series …
Pre-loading of femoral head on its neck at 2000 N and measurement of the head extraction force in the thrid series.

All the results were in compliance with the requirements set forth by the FDA. Risk to health have been addressed through the specified materials, Processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations.

CONCLUSION:

All these elements show the safety and effectiveness of our product. Our 10/12 cone Alumina heads are substantially equivalents to the selected predicate device in terms of intended use, material, safety and effectiveness.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 1 2005

Ms. Christine Quendez Regulatory Affairs Manager Fournitures Hospitalieres Industrie 6 rue Nobel Z.I. De Kernévez 29000 Quimper, France

Re: K050556

Trade/Device Name: Alumina Heads 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: April 18, 2005 Received: April 21, 2005

Dear Ms. Quendez:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for referenced above and nove to legally marketed predicate devices marketed in interstate commerce ass suited in the enactment date of the Medical Device Amendments, or to devices that provision in the recordance with the provisions of the Federal Food, Drug, and Cosmetic nu ( 6 ct) 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 thereore, manisons 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 rr your device to such additional controls. Existing major regulations affecting your device can be may of subject to sam adam 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 r that FDA has made a determination that your device complies with other requirements of the Act or that I Dri has mude a acterinations administered by other Federal agencies. You must comply with all 1 cacraf statutes and 16 this and limited to: registration and listing (21 CFR Part 807); an all 1 ce 1 c requirements as a manufacturing practice requirements as set forth in the quality labeling (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 – Ms. Christine Quendez

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin mailtoning of substantial equivalence of your device to a legally premarket notification. "The I Driving of oation 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 If you desire specific advice for your ac (240) 276-0120. Also, please note the regulation entitled, Comact the Office of Complanes as (210). The Part 807.97). You may obtain other Misoranding by reference to promisibilities under the Act from the Division of Small general information on your responsionner Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Stupt Rurde

A. Miriam C. Provost, Ph.D.

Mirian C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K050556

Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

Alumina Heads

Prosthetic replacement of the femoral head associated with a hip prosthesis having a taper compatible with the head taper, and with a prosthetic acetabulum having an inside diameter compatible with that of the head.

The alumina head can only be used with polyethylene inserts.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over the counter Use (21 CFR 801 Subpart C)

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

(Division Sign-Off)
Division of General, Restorative, and Neurological Devices	Page 1 of 1
510(k) Number	K050556

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.