(29 days)
The Tornier Total Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated in the following cases : to relieve severe pain of significant disability in degenerative, theumatoid or traumatic disease of the elow joint; correction of functional deformities; revision procedures where other treatments or device have failed, treatment of fractures that are unmanageable using other techniques. This device is intonded for cemented use only.
The present device modification concerns the evolution of the radial head, which is a part of the I to present device modified scommons on one the the humeral and the ulmar component are unchanged. The radial head is composed of a radial head. The modification consists on the addition of a smaller diameter stem (5 mm ) to the previous range of components. Shance than elect stom 7 to the previous to the cleared device. The assembly of the stem and the radial head is unchanged. The manufacturing methods, intended use, packaging and sterilization of the subjected device are identival to the predicate device.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth for a study.
The document is a 510(k) premarket notification for a device modification to the Tornier Total Elbow Prosthesis. It describes the device, its intended use, and materials. The FDA letter indicates that the device is substantially equivalent to legally marketed predicate devices. However, it does not include the details of any study conducted to prove the device meets specific acceptance criteria using the information you requested.
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JUN 1 9 2001
Special 510{k}: Device modification - Premarket Notification 510(k) Tornier Total Elbow Prosthesis
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Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
1) Device name
| Trade name: | Tornier Total Elbow Prosthesis |
|---|---|
| Common name: | Total Elbow Prosthesis |
| Classification name: | Elbow joint metal/polymer semi-constrained or constrained cemented prosthesis |
2) Manufacturer
Tornier S.A. B.P. 11 - Rue Doyen Gosse 38330 Saint Ismier - France
Classification 3)
8 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis. Il or metal/polymer constrained cemented prosthesis.
| § 888.3150 Elbow joint metal/metal of metal/p | |
|---|---|
| Classification panel: | Orthopedic |
| Product code: | 87 JDB / 87JDC |
| Device class: | Class II |
Device description : 4)
The present device modification concerns the evolution of the radial head, which is a part of the I to present device modified scommons on one the the humeral and the ulmar component are unchanged.
The radial head is composed of a radial head. The modification consists on the addition of a smaller diameter stem (5 mm ) to the previous range of components.
Shance than elect stom 7 to the previous to the cleared device. The assembly of the stem and the radial head is unchanged.
The manufacturing methods, intended use, packaging and sterilization of the subjected device are identival to the predicate device.
5) Indications :
The Tornier Total Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated in the following cases : to relieve severe pain of significant disability in degenerative, theumatoid or traumatic disease of the elow joint; correction of functional deformities; revision procedures where other treatments or device have failed, treatment of fractures that are unmanageable using other techniques. This device is intonded for cemented use only.
6) Materials :
Humeral implant components are available in CoCr alloy according to standard ISO 5832-7 or ISO 5832-4 The ulnar and radial components are made of CoCr alloy according to standard ISO 5832-7 or ISO 5832-4, and UHMWPE according to standard ISO 5834-2.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 2001
Ms. Irene Gosset Regulatory Affairs Department Tornier S.A. 161, Rue Lavoiser 38330 Montbonnot France
Re: K011567
Trade Name: Tornier Total Elbow Prosthesis Regulation Number: 888.3160 and 888.3150 Regulatory Class: II Product Code: JDB and JDC Dated: May 16, 2001 Received: May 21, 2001
Dear Ms. Gosset:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations
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Page 2 - Ms. Irene Gosset
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
BMthlellursto
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices
Enclosure
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Special 510(k): Device modification - Premarket Notification 510(k) Tornier Total Elbow prosthesis
| Page | 01-----------AMERICAN | 1------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|---|---|---|
| ੇ |
510(k) Number (if known): __ KOUS62
Tornier Total Elbow Prosthesis Device name:
Indication for use:
The Tornier Total Elbow Prosthesis is intended for total elbow arthroplasty. The Torner Total Thoow Treathers may be indicated in the following cases :
Prosthetic replacement with this device may be indicated in the releventaid or to relieve severe pain or significant disability of an degenerative, renision traumatic disease of the elbow joint; correction of functional deformities; revision traumatic disease of the cibow jom, collection of this is the it is the mont of fractures that are unmanageable using other techniques.
This device is intendod for cemented use only.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
Butcherville to chu
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K011567
OR Over-The-Counter Use
Prescription use
(Per 21 CFR 801.109)
(Optional format 1-2-96)
8
Tomier S.A.
§ 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.