(63 days)
No
The description focuses on the mechanical properties and design of a bone plate system, with no mention of AI or ML.
Yes
The device is described as an "internal fixation" system for "fractures of the distal radius," which is a treatment for a medical condition.
No
This device is an implantable plate system used for internal fixation of distal radius fractures, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a distal radius plating system made of titanium alloy plates and bone screws, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "internal fixation of fractures of the distal radius." This describes a surgical procedure to stabilize a broken bone.
- Device Description: The description details a physical implant (plates and screws) made of titanium alloy, designed to be surgically attached to bone.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status or disease. IVDs are used for diagnosis, monitoring, or screening.
This device is a surgical implant used for orthopedic fixation.
N/A
Intended Use / Indications for Use
The Rogachefsky Distal Radius Plates are intended for use in internal fixation of fractures of the distal radius.
Product codes
HRS
Device Description
This submission describes a distal radius plating system including one volar and two dorsal plates ( left and right configurations) with a curved profile designed to fit the contour of the distal radius. It is intended for use in internal fixation of fractures of the distal radius. Plates are a modified T shape and are 1.0 mm thick. The plates are manufactured from titanium alloy , Ti 6Al 4V, which conforms to ASTM specification F136. The Rogachefsky Distal Radius Plates are attached to the underlying bone using bone screws previously cleared in the Leibinger Radius Reconstruction Plate System [RRPS] 510(k) submission K961496. The plates are available in sterile and non-sterile versions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUN 1 0 1998
Image /page/0/Picture/1 description: The image shows a handwritten sequence of characters. The sequence appears to be 'K981/283'. The characters are written in a bold, somewhat rough style, giving them a distinct and slightly irregular appearance. The overall impression is that of a quickly written or stylized alphanumeric code.
510(k) Summary
Rogachefsky Distal Radius Plates
Device:
For information contact:
John Dichiara Director of Regulatory Affairs and Public Policy Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Tel: (201) 507-7386 Fax: (201) 507-6870
Date Prepared:
April 16, 1998
Summary:
This submission describes a distal radius plating system including one volar and two dorsal plates ( left and right configurations) with a curved profile designed to fit the contour of the distal radius. It is intended for use in internal fixation of fractures of the distal radius. Plates are a modified T shape and are 1.0 mm thick. The plates are manufactured from titanium alloy , Ti 6Al 4V, which conforms to ASTM specification F136. The Rogachefsky Distal Radius Plates are attached to the underlying bone using bone screws previously cleared in the Leibinger Radius Reconstruction Plate System [RRPS] 510(k) submission K961496. The plates are available in sterile and non-sterile versions.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the RRPS Distal Radius Plating System (Howmedica K961496) and the Alta® Tibial/Upper Extremity Plating System Metaphyseal T Plate (Howmedica K885250).
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing right, arranged in a stacked formation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 1998
Mr. John F. Dichiara Director of Regulatory Affairs and Public Policy Howmedica Inc. Pfizer Medical Technology Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
Re: K981283 Trade Name: Rogachefsky Distal Radius Plates Regulatory Class: II Product Code: HRS Dated: April 8, 1998 Received: April 8, 1998
Dear Mr. Dichiara:
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, Druq, 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 aqainst 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. ਜੋ 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 requlation 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. John F. Dichiara
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,
Celia M. Witten, Ph.D.
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
3
Indications for Use
510(k) Number (if known):
Device Name: Rogachefsky Distal Radius Plates
Indications for Use:
The Rogachefsky Distal Radius Plates are intended for use in internal fixation of fractures of the distal radius.
(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) and/or prescription use, and/or over-the-counter use, and/or over-the-counter use (optional format 1-2-96)
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices K961203
510(k) Number
. .