(48 days)
The ULTiMAX™ brand Trochanteric Intramedullary Rod System is indicated for single use to stabilize intertrochanteric and subtrochanteric fractures of the proximal femur.
ULTiMAX™ Trochanteric Intramedullary Rod System II
The provided text is an FDA 510(k) clearance letter for a medical device called the "ULTiMAX™ Trochanteric Intramedullary Rod System II". This letter confirms that the device has been found substantially equivalent to a predicate device and can be marketed.
However, the letter does not contain any information about acceptance criteria or the study that proves the device meets specific performance criteria. It is a regulatory clearance document, not a detailed technical report or a clinical study summary.
Therefore, I cannot provide the requested information based only on the provided input. The document's purpose is to grant market authorization based on substantial equivalence, not to detail the specific performance validation results.
To answer your request, I would need a different type of document, such as:
- A pre-market submission summary (e.g., a 510(k) summary or an IDE report)
- A clinical study report
- A peer-reviewed publication about the device's performance
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three wavy lines that resemble a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 1999
Mr. Danny Hodgeman Biodynamic Technologies, Inc. 1425 East Newport Center Drive Deerfield Beach, Florida 33442
K990436 Re: ULTiMAX™ Trochanteric Intramedullary Trade Name: Rod System II Regulatory Class: Product Code: HSB Dated: January 29, 1999 February 11, 1999 Received:
Dear Mr. Hodgeman:
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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 In addition, FDA may publish further announcements action. 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 - Mr. Danny Hodgeman
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" (21 CFR 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/dsmamain.html".
Sincerely yours,
a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
| 510(k) Number: | Unknown |
|---|---|
| Device Name: | ULTIMAX ™ Trochanteric Intramedullary Rod System |
Indications For Use:
The ULTiMAX™ brand Trochanteric Intramedullary Rod System is The OLTIMAX - Drand Tronantono Intrainsaulary Not by North
indicated for single use to stabilize intertrochanteric and subtrochanteric fractures of the proximal femur.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K990436 |
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | --- | ---- | ---------------------- |
(Optional Format 1-2-96)
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.