ALUMINA HEAD

{0}------------------------------------------------ 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 Image /page/0/Picture/11 description: The image is a logo with the letters AFAQ stacked on top of each other. The top half of the logo is black with white letters, and the bottom half is white with black letters. Below the letters, the text "ISO 9001" is printed in a sans-serif font. Underneath that, the text "AFAQ N 1996/0540" is printed in a smaller font size. 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: Image /page/0/Picture/18 description: The image shows a logo with the word "SHITEM" written in a bold, sans-serif font. Above the word, there is a stylized graphic that resembles a distorted or abstract letter "S" or a pair of curved shapes facing each other. The graphic is enclosed within a square border, giving the logo a structured and contained appearance. The overall design is simple, yet distinctive, suggesting a modern and potentially corporate identity. 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: 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. 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 {1}------------------------------------------------ $$ \begin{pmatrix} \pi_1 \circ \pi_2 & \mathcal{O} \\ \pi_1 \circ \pi_2 & \mathcal{O} \end{pmatrix} \cong \mathcal{S} \circ \mathcal{O} \mathcal{L} \mathcal{O} \mathcal{N} $$ ### 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. {2}------------------------------------------------ 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. {3}------------------------------------------------ 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 {4}------------------------------------------------ # 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 __