(29 days)
Not Found
Not Found
No
The summary describes a mechanical implant (locking plate system) and contains no mention of software, algorithms, image processing, AI, or ML.
Yes
The device is described as a system to "stabilize distal fractures of the radius," which indicates it is used for the treatment or mitigation of an injury or disease.
No
Explanation: This device is a surgical implant (plate system) used to stabilize fractures, not to diagnose a medical condition.
No
The device description clearly identifies it as a "Distal Radial (Volar) Locking Plate System," which is a physical implant used to stabilize bone fractures. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "stabilize distal fractures of the radius." This describes a surgical implant used to treat a physical injury.
- Device Description: The description is for a "Distal Radial (Volar) Locking Plate System," which is a type of orthopedic implant.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, tissue, etc.).
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Use in a laboratory setting for diagnostic purposes.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is a surgical implant used for mechanical stabilization.
N/A
Intended Use / Indications for Use
The ULTiMAX™ brand Distal Radial (Volar) Locking Plate System is indicated for single use to stabilize distal fractures of the radius.
Product codes
HRS, HWC
Device Description
ULTIMAX™ Distal Radial (Volar) Locking Plate System
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
distal fractures of the radius
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles a bird or a human figure in profile, with flowing lines representing movement or energy.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 1999
Mr. Danny Hodgeman Product Engineer Biodynamic Technologies, Inc. 1425 East Newport Center Drive Deerfield Beach, Florida 33442
K990481 Re: ULTIMAX™ Distal Radial (Volar) Trade Name: Locking Plate System Requlatory Class: II Product Code: HRS and HWC Dated: February 8, 1999 February 16, 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 reguirements 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 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 Also, please note the Office of Compliance at (301) 594-4639. 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,
Celia M. Witten, Ph.D.,
Celia 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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K990481
Page 1 of 1
| 510(k) Number: | Unknown |
|---|---|
| Device Name: | ULTIMAX ™ Distal Radial (Volar) Locking Plate System |
Indications For Use:
The ULTiMAX™ brand Distal Radial (Volar) Locking Plate System is indicated for single use to stabilize distal fractures of the radius.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K990481
Prescription Use X
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)