GRACE DYNAMIC TORP

K091187

Details

Applicant
GRACE MEDICAL, INC.
Applicant Information
Address
8500 WOLF LAKE DR., STE. 110
MEMPHIS  TN

Contact
JEFF COBB
Type
Traditional
Product Code
ETA
Product Code Details
Device Name
Replacement, Ossicular Prosthesis, Total
Regulation Number
874.3495
Device Class
2


Citations (Parsed from OCR summary text - may contain errors)
510(k) Number Device Name Applicant
K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEM GRACE MEDICAL, INC.
GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL GRACE MEDICAL, INC.
AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSEL HEINZ KURZ GMBH MEDIZINTECHNIK
Summary (OCR text may contain errors)
Food ad
DrugSEP 1 4 2009
Foodand rugAdministration
S510(k) Notifcation- GraceDynamic OssicularReplacement Prostheses
Page 14of 15
April20, 2009
510(K) SUMMARY
GRACE DYNAMIC OSSICULAR REPLACEMENT PROSTHESES
Trade Name: Grace Dynamic Ossicular Replacement Prostheses
Common Name: Ossicular Replacement Prostheses
Classification Name: Ossicular Replacement Prostheses
510(k) No.: K091187
Official Contact: Jeff Cobb
Consultant
Grace Medical, Inc.
8500 Wolf Lake Drive, Suite 10
Memphis, TN 38133
Telephone: (901) 380-7000
Telefax: (901) 380-7001
Date Prepared: April 20, 2009
Predicate Devices
1. Kurz Aerial TORP manufactured by Heinz Kurz GmbH Medizintechnik and cleared
via 510(k) No. K972585.
2. Grace Medical's K-Helix Piston and Porp Partial Ossicular Replacement Prostheses,
cleared via 510(k) No. K080070.
*3. Grace Medical's Adjustable Length TORP cleared via 510(k) No. K061853.
Intended Use - The Grace Dynamic 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 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.
Material(s) - The Grace Dynamic Ossicular Replacement Prostheses are manufactured from the
same materials as the predicate devices:
Foodand DrugAdministration
510(k) Notification- Grace Dynamic OssicularReplacement Prostheses
Page 15 of 15
April 20, 2009
(i) Unalloyed titanium (ASTM F67)
(ii) Titanium alloy (ASTM F136)
(iii) Medical Grade Silicone
(iv) ASTM F 1185 - Hydroxylapatite
Comparisons
1. The Grace Dynamic Ossicular Replacement Prostheses are similar / dissimilar to the
Kurz Aerial TORP in the following ways:
* Intended use - The Grace Dynamic ORP bridges the gap between footplate
and TM or the stapes and TM; whereas, the Kurz TORP bridges the gap
between footplate and TM.
· Materials of construction - both devices contain titanium or titanium alloy;
whereas, the Grace Dynamic Ossicular Replacement Prostheses also contains
medical grade silicone and hydroxylapatite.
2. The Grace Dynamic Ossicular Replacement Prostheses are similar / dissimilar to the
Grace Medical K-Helix Piston in the following ways:
· Intended use - The Grace Dynamic ORP bridges the gap between footplate
and TM or the stapes and TM; whereas, the K-Helix Piston bridges the gap
between the footplate and the remnant of the incus.
· Materials of construction - both devices contain titanium or titanium alloy;
whereas, the Grace Dynamic ORP also contains medical grade silicone and
hydroxylapatite.
3. The Grace Dynamic Ossicular Replacement Prostheses are similar / dissimilar to the
Grace Medical Fixed Length TORP's inthe following ways:
* Intended use - The Grace Dynamic ORP bridges the gap between footplate
and TM or the stapes and TM; whereas, the Grace Medical Fixed Length
TORP bridges the gap between footplate and TM.
* Materials of construction - both devices contain titanium or titanium alloy, a
medical-grade silicone sleeve, and hydroxylapatite.
Differences between the Grace Dynamic Ossicular Replacement Prostheses and the predicate
devices should not affect the safety or effectiveness.
DEPARTMENT OF HEALTH &HUMAN SERVICES
Food and Drug Administration
10903 New Hampshire Avenue
SEP 14 2009 Document Mail Center - W066-G609
Silver Spring, MD 20993-0002
Grace Medical, Inc.
c/o Mr. Jeff Cobb
Consultant
Regulatory Affairs & Quality
8500 Wolf Lake Drive, Suite 110
Memphis, TN 38133
Re: K091187
Trade/Device Name: Grace Dynamic Ossicular Replacement Prosthesis
Regulation Number: 21 CFR 874.3495
Regulation Name: Total ossicular replacement prosthesis
Regulatory Class: II
Product Code: ETA
Dated: August 4, 2009
Received: August 5, 2009
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 ofa 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 additional controls. Existing major regulations affecting your device can be
found in the Code ofFederal 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); medical device reporting (reporting of medical
device-related adverse events) (21 CFR 803); 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.
Page 2 - Mr. Cobb
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
go to http://www.fda. gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please
note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21
CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of
Surveillance and Biometrics/Division of Postmarket Surveillance.
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/industrv/support/index.html.
Sincerely yours
Malvina B. Eydelman, M.D.
Director
Division of Ophthalmic, Neurological,
* and Ear, Nose and Throat Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
FoodandDrugAdministration
510(k) Notification- Grace Dynamic OssicularReplacement Prostheses
Page3 ofJ7
April21, 2009
510(k) Number:
Device Name: Grace Dynamic Ossicular Replacement Prostheses
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 X OR Over-The-Counter Use
(Per 21 CFR 801.109) (Optional Format 1-2/96)
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Nose and ThroatDevices
510(k)Number, Koc ((~ L

Referenced By (Parsed from OCR summary text - may contain errors)
No references found!