NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE

{0}------------------------------------------------ ## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS Grace Medical Partial Ossicular Replacement Prostheses GEC - 6 2006 | Trade Name: | The family of Grace Medical Nitinol Partial Ossicular Replacement<br>Prostheses consists of:<br>Nitinol Locking Incudo-Stapedial Joint Nitinol Locking Angular Piston Nitinol Locking Piston Nitinol Locking Malleus Piston Nitinol Locking PORP Footplate Shoe | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Partial Ossicular Replacement Prostheses | | Classification Name: | Partial Ossicular Replacement Prostheses (CFR 21 §<br>874.3450) | | Official Contact: | Jeff Cobb<br>Vice President of Regulatory Affairs & Quality<br>Grace Medical, Inc.<br>8500 Wolf Lake Drive, Suite 110<br>Memphis, TN 38133 | | Telephone: | (901) 380-7000 | | Telefax: | (901) 380-7001 | | Date Prepared: | November 8, 2006 | ### Predicate Devices - 1) SMart ISJ Prosthesis manufactured by Gyrus ENT LLC and cleared via 510(k) No. K033554. - 2) SMart Piston manufactured by Gyrus ENT LLC and cleared via 510(k) No. K003214. - 3) Angular Prosthesis (Plester) manufactured by Heinz Kurz GmbH Medizintechnik and cleared via 510(k) No. K972492. - 4) CliP Piston MVP manufactured by Heinz Kurz GmbH Medizintechnik and cleared via 510(k) No. K042503. - 5) CliP Piston aWengen manufactured by Heinz Kurz GmbH Medizintechnik and cleared via 510(k) No. K021479. - 6) Adjustable and Fixed-Length PORPs manufactured by Grace Medical, Inc. and cleared via 510(k) No. K061853. - 7) Partial Ossicular Replacement Prosthesis manufactured by Grace Medical, Inc. and cleared via 510(k) K972815. Intended Use - The Grace Medical Partial Ossicular Replacement Prostheses have the same primary intended use as the predicate devices. An ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner car. Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications for use include: {1}------------------------------------------------ - (a) Chronic middle ear disease, - (b) Otosclerosis, - (c) Congenital fixation of the stapes, - (d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and - (e) Surgically correctible injury to the middle ear from trauma. Material(s) - The Grace Medical Partial Ossicular Replacement Prostheses are manufactured from the same materials as the predicate devices: - (i) Nitinol (ASTM F2063-05) - (ii) Unalloyed titanium (ASTM F67) - (iii)Titanium alloy (ASTM F136) - (iv) Hydroxylapatite (ASTM F1185) - (v) Fluoroplastic (USP Class VI for plastics, ASTM D1710 and ASTM F754) - (vi) Medical grade silicone ### Comparison Charts . ### NITINOL LOCKING INCUDO-STAPEDIAL JOINT | | Nitinol Locking Incudo-Stapedial Joint | SMart<br>ISJ<br>(Gyrus) | SMart<br>Piston<br>(Gyrus) | Angular<br>Prosthesis<br>(Kurz) | Similarities or Differences | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|----------------------------|---------------------------------|------------------------------------------------------------------------------------------------| | Intended Use | An ossicular replacement prosthesis is a device<br>intended to be implanted for the functional<br>reconstruction of segments of the ossicular chain and<br>facilitates the conduction of sound wave from the<br>tympanic membrane to the inner ear. | Same | Same | Same | Same | | Material(s) | Nitinol | Nitinol | Nitinol<br>Fluoroplastic | Titanium | Substantially Equivalent | | Method of<br>Attachment | Manual or Heat Crimp-Assist | Same | Same | Manual | Same as SMart ISJ and<br>SMart Piston. Different<br>than but SE to Kurz<br>Angular Prosthesis. | | How<br>Supplied | Sterile | Sterile | Sterile | Sterile | Same | ### NITINOL LOCKING ANGULAR PISTON | | Nitinol Locking Angular Piston | SMart<br>ISJ<br>(Gyrus) | SMart Piston<br>(Gyrus) | Angular<br>Piston<br>(Kurz) | Similarities or<br>Differences | |-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|--------------------------|-----------------------------|--------------------------------| | Intended<br>Use | An ossicular replacement prosthesis is a device intended to be<br>implanted for the functional reconstruction of segments of the<br>ossicular chain and facilitates the conduction of sound wave from<br>the tympanic membrane to the inner car. | Same | Same | Same | Same | | Material(s) | Nitinol<br>Titanium | Nitinol | Nitinol<br>Fluoroplastic | Titanium | Substantially<br>Equivalent | | Lengths | 3.0mm to 9.0mm | n/a | 3.0mm to<br>6.0mm | 4.25mm to<br>4.75mm | Substantially<br>Equivalent | | How<br>Supplied | Sterile | Sterile | Sterile | Sterile | Same | {2}------------------------------------------------ # NITINOL LOCKING PISTON | | Nitinol Locking Piston | SMart<br>ISJ<br>(Gyrus) | SMart Piston<br>(Gyrus) | Angular<br>Piston<br>(Kurz) | Similarities or<br>Differences | |-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|--------------------------|-----------------------------|--------------------------------| | Intended<br>Use | An ossicular replacement prosthesis is a device intended to<br>be implanted for the functional reconstruction of segments<br>of the ossicular chain and facilitates the conduction of<br>sound wave from the tympanic membrane to the inner ear. | Same | Same | Same | Same | | Material(s) | Nitinol<br>Titanium<br>Fluoroplastic | Nitinol | Nitinol<br>Fluoroplastic | Titanium | Substantially<br>Equivalent | | Lengths | 3.0mm to 9.0mm | n/a | 3.0mm to 6.0mm | 4.25mm to<br>4.75mm | Substantially<br>Equivalent | | How<br>Supplied | Sterile | Sterile | Sterile | Sterile | Same | # NITINOI. LOCKING MALLEUS PISTON | | Nitinol Locking Malleus Piston | CliP Piston<br>MVP<br>(Kurz) | CliP Piston<br>aWengen<br>(Kurz) | Similarities or<br>Differences | |-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|----------------------------------|--------------------------------| | Intended<br>Use | An ossicular replacement prosthesis is a device intended to be implanted for<br>the functional reconstruction of segments of the ossicular chain and facilitates<br>the conduction of sound wave from the tympanic membrane to the inner ear. | Same | Same | Same | | Material(s) | Nitinol<br>Titanium<br>Fluoroplastic | Titanium | Titanium | Substantially<br>Equivalent | | Lengths | 3.0mm - 9.0mm | 5.00mm -<br>6.25mm | 4.0mm -<br>5.5mm | Substantially<br>Equivalent | | How<br>Supplied | Sterile | Sterile | Sterile | Same | ### Nitinol Locking PORP | | Nitinol Locking PORP | SMart<br>ISJ<br>(Gyrus) | SMart Piston<br>(Gyrus) | Grace Adjustable and<br>Fixed-length PORPs | Similarities or<br>Differences | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|--------------------------|-----------------------------------------------------------------------------------------|--------------------------------| | Intended<br>Use | An ossicular replacement prosthesis is<br>a device intended to be implanted for<br>the functional reconstruction of<br>segments of the ossicular chain and<br>facilitates the conduction of sound<br>wave from the tympanic membrane to<br>the inner ear. | Same | Same | Same | Same | | Shaft<br>Material(s) | Nitinol<br>Titanium<br>Silicone (sleeve on adjustable models) | Nitinol | Nitinol<br>Fluoroplastic | Titanium<br>Silicone (sleeve on adjustable<br>models) | Substantially<br>Equivalent | | Head<br>Material(s) | Titanium<br>Hydroxylapatite | No<br>head | No head | Titanium<br>Hydroxylapatite | Same | | Lengths | Fixed Sizes: 0.5mm to 9.0mm<br>Adjustable model - Trimmed<br>intraoperatively to length | n/a | 3.0mm to 6.0mm | Fixed Sizes: 0.5mm to 9.0mm<br>Adjustable model - Trimmed<br>intraoperatively to length | Substantially<br>Equivalent | | How<br>Supplied | Sterile | Sterile | Sterile | Sterile | Same | {3}------------------------------------------------ #### FOOTPLATE SHOE | | Footplate Shoe | Grace HA Footplate Shoe<br>K972815 | Similarities or<br>Differences | |-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|--------------------------------| | Intended Use | An ossicular replacement prosthesis is a device intended to<br>be implanted for the functional reconstruction of segments<br>of the ossicular chain and facilitates the conduction of sound<br>wave from the tympanic membrane to the inner ear. | Same | Same | | Material(s) | Nitinol<br>Titanium<br>Hydroxylapatite | Hydroxylpaptite | Substantially<br>Equivalent | | Accommodates<br>Shafts with<br>Diameters: | 0.3mm to 1.07mm | 1.07mm | Substantially<br>Equivalent | | How Supplied | Sterile | Sterile | Same | Differences between the Grace Medical Modified Partial Ossicular Replacement Prostheses and the predicate devices should not affect the safety or effectiveness. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Grace Medical, Inc. c/o Jeff Cobb Regulatory Affairs & Quality 8300 Wolf Lake Drive Suite 110 Memphis, TN DEC = 6 2006 Re: K063374 Trade/Device Name: Partial Ossicular Replacement Prostheses, Nitinol Incudo-Stapedial Joint, Nitinol Angular Piston, Nitinol Piston, Nitinol Malleus Piston, Nitinol PORP and Footplate Shoc Regulation Number: 21 CFR 874.3450 Regulation Name: Partial ossicular replacement prosthesis Regulatory Class: Class II Product Code: ETB Dated: November 8, 2006 Received: November 8, 2006 Dear Mr. Cobb: 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 (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. {5}------------------------------------------------ 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 premated nevice 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) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, M.B. Eychler S.M.D. Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # 510(k) Number: ¥063374 Device Name: Partial Ossicular Replacement Prostheses including: Nitinol Incudo-Stapedial Joint, Nitinol Angular Piston, Nitinol Piston, Nitinol Malleus Piston, Nitinol PORP, and Footplate Shoe ## Indications for Use: An ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications for use include: - (a) Chronic middle ear disease, - (b) Otosclerosis. - (c) Congenital fixation of the stapes, - (d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and - (e) Surgically correctible injury to the middle ear from trauma. ## (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) Karus boha X e and Throat Devis 510(k) Number K063374