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. This prosthesis may be used for degenerative joint 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 hip, diastrophic variant, slipped capital epiphysis, non-union.

Device Description

Alumina heads are made of Biolox forte alumina (trademark of CERAMTEC) according to ASTM F 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.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Performed)	Reported Device Performance
Fatigue test (to rupture)	In compliance with FDA requirements / selected standard
Static compression test (to rupture)	In compliance with FDA requirements / selected standard
Static compression test (at 2000 N)	In compliance with FDA requirements / selected standard
Head extraction force measurement	In compliance with FDA requirements / selected standard
Material characteristics (adherence to FDA guidance "Guidance document for the preparation of prematerial notifications for ceramic ball hip systems" dated Jan 10, 1995)	All requirements set forth in the guidance document were met.
Compliance with ASTM F 6474 (for Biolox forte alumina)	Alumina heads are made of Biolox forte alumina according to ASTM F 6474 standard.

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

The document does not explicitly state the numerical sample size used for the test set for the performance tests (fatigue, static compression, head extraction). It only mentions "two series of tests."

The data provenance is not specified beyond the tests being performed by the manufacturer seeking clearance in France ("Fournitures Hospitalières Industrie"). It is retrospective, as the tests were conducted prior to the 510(k) submission.

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

This information is not applicable as the studies are performance tests on a physical device, not an AI/software device that requires human expert ground truth for labeling data. The "ground truth" for these tests is the physical behavior of the device under stress, measured against engineering standards.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3.

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

A MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools or systems where human readers interpret medical images or data. The device in question is a physical orthopedic implant (alumina femoral head), which does not involve human readers for its primary function.

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

This information is not applicable as the device is a physical medical implant, not an algorithm or AI system. The "performance" being evaluated is the mechanical integrity and material properties of the implant itself.

7. Type of Ground Truth Used

The ground truth for the device's performance is based on:

Engineering Standards: Specifically ASTM F 6474 for the material (Biolox forte alumina).
Regulatory Requirements: "Requirements set forth by the FDA" for the performance tests, and "FDA's guideline: 'Guidance document for the preparation of prematerial notifications for ceramic ball hip systems' dated January 10, 1995" for material characteristics.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical implant, not an AI/ML algorithm that requires a "training set." The manufacturing process would involve process controls and quality assurance, but not in the sense of a data training set for an AI model.

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

This information is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image shows a logo with the letters 'FH' in a bold, sans-serif font stacked on top of each other. Below the letters, there are two lines of text that read 'FOURNITURES' and 'HOSPITALIERES'. There is a thin horizontal line separating the letters from the text. The logo appears to be for a company that provides hospital supplies.

NOV 1 7 2004

K042035 (pg 1 of 2)

S. rue Nobel ZI. DE KERNEVEZ 29000 QUIMPER FRANCE Tél : 02 98 55 68 95 Fax : 02 98 53 42 13

510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS ALUMINA HEADS

SPONSOR IDENTIFICATION:

Fournitures Hospitalières Industrie 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:

JULY 10th, 2004

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DEVICE TRADE NAME: DEVICE COMMON NAME: CLASSIFICATION NAME:

ALUMINA HEADS

Ceramic Femoral Head

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

Image /page/0/Picture/15 description: The image shows a logo with the letters 'G' and 'MED' stacked on top of each other. The 'G' is larger and bolder than 'MED'. Below the logo, the text 'EN 46001' is displayed. The logo appears to be a certification mark or symbol related to medical devices or quality management systems.

Class II REGULATORY CLASS: DEVICE PRODUCT CODE: 87 LZO PANEL CODE: 21 CFR 888.3353

DEVICE DESCRIPTION:

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Alumina heads are made of Biolox forte alumina (trademark of CERAMTEC) according to ASTM F 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.

INDICATIONS FOR USE:

S A S.AU CAPTAL DE 9 4 694, 0 € - Baques CRCA Quinper - R.C Quinper - R.C Quinper - R.C Quinper / S.B.R - SRET 303 S.O. 15 (1)trajonmprovation FR 7 00 33.9 250

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$$
\begin{pmatrix}
\pi_1 \circ \pi_2 & \mathcal{O} \
\pi_1 \circ \pi_2 & \mathcal{O}
\end{pmatrix}
\cong \mathcal{S} \circ \mathcal{O} \mathcal{L} \mathcal{O}
\mathcal{N}
$$

PREDICATE DEVICES:

PREDICATE DEVICES:
Numerous alumina heads made of Biolox forte have been cleared three predicate devices based Numerous alumina neads made of Diolox Introl have selected three predicate devices based
by the Food and Drug Administration (FDA). We have second secures by the Food and Drug Administration (1 ce manufacturing and design features.

These predicate devices are:

esc predicate de vices are:
Apex Modular Alumina Femoral Head (K012918), Apex Surgical -
Apex Modular Alumina Femoral Head (1167877777777777777787777787), Smith & Nephew -
Diolox Authma Coramic Head Prosthesis (K990261), Plus Orthopedics -

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

COMPARISON OF TECHNODOOTCAD Crand substantial similar indications for use as the Our alumina neads nave the same mended as and of the same material (Biolox forte), are available in similar diameters and lengths, with similar designs.

similar diameters and lengths, whill shinks accepts.
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 prematerial we have for ceramic ball hip systems" dated January 10, 1995 to compare it our material notifications for ceraint ban mp 35stems - attest remairements. Our alumina heads reach all the requirements set up in this guidance document.

PERFORMANCES:

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

Fatigue test and static compression test to rupture in the first series, and -
Fallgue lest and static compression test at 2000 N and measurement of the head extraction a force in the second series.

All the results were in compliance with the requirements set forth by the FDA.

All the results were in comphance must the specified materials. Processing controls, quality NISK to nearth have bool addressed ation for a

CONCLUSION:

CONCEON.
All these elements show the safety and effectiveness of our product. Our Alumina heads are All these elements show the selected predicate device in terms of intended use, material. safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 17 2004

Ms. Christine Quendez Regulatory Affairs Manager Fournitures Hospitalieres Industries ZI de Kernevez 6 rue Nobel 29000 Quimper France

Received: November 1, 2004

Re: K042035

Trade/Device Name: Alumina heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. Regulatory Class: II Product Code: LZO Dated: November 1, 2004

Dear Quendez:

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. Christine Quendez

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 (240) 276-0120. 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,

L. Mark H. Milken

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):

Device Name:

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

The alumina head can only be used with

This prothesis may be used for degenerative joint disease such as osteoarthritis and avascular necrosis, correction of functional deformity, rheumatoid arthritis, revision procedure where

congenital dislocation, femoral neck

trochanteric fractures, traumatic arthritis, fused

diastrophic variant, slipped

compatible with that of the head.

polvethylene inserts.

other devices or

epiphysis, non-union.

14042035

Indications for Use:

R. Mark A. Milkersen
Division Sign-Off

Division of General, Restorative, and Nearological Devices

516(e) Number K042035

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

hip,

Over the counter Use (21 CFR 801 Subpart C)

treatments have failed,

and

capital

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page __ of __

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.