(59 days)
The ULTiMAX™ brand Distal Femoral Intramedullary Rod System is indicated for single use to stabilize distal femoral fractures, including supracondylar fractures, severely comminuted supracondylar fractures with difficult intra-articular extension, fractures that require stabilization of the femoral condylar segment, distal fractures in osteoporotic bone, pathologic fractures, pseudoarthrosis, malunions and failed distal femoral osteosynthesis.
ULTiMAX™ Distal Femoral Intramedullary Rod System
I am sorry, but based on the provided document, I cannot extract information about the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for the ULTiMAX™ Distal Femoral Intramedullary Rod System, which primarily discusses the substantial equivalence of the device to a predicate device and its indications for use. It does not contain details about specific performance acceptance criteria or performance study results.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1
Mr. Danny Hodgeman Biodynamic Technologies, Inc. 1425 East Newport Center Drive Deerfield Beach, Florida 33442
K981230 Re: ULTIiMAX™ Distal Femoral Trade Name: Intramedullary Rod System Regulatory Class: II Product Code: HSB Dated: March 31, 1998 Received: April 3, 1998
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 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 Requlations, Title 21, Parts 800 to 895. ਸਿ 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 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 requlations.
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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,
C. Col. M. Whitacre, Ph. D., M.
ia 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
ULTiMAX™ Distal Femoral Intramedullary Rod System Device Name:
Indications For Use:
The ULTiMAX™ brand Distal Femoral Intramedullary Rod System is indicated for single use to stabilize distal femoral fractures, including supracondylar fractures, severely comminuted supracondylar fractures with difficult intra-articular extension, fractures that require stabilization of the femoral condylar segment, distal fractures in osteoporotic bone, pathologic fractures, pseudoarthrosis, malunions and failed distal femoral osteosynthesis.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K981230 |
| 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.