(12 days)
Not Found
No
The summary describes a system of orthopedic plates, fasteners, and surgical tools, with no mention of software, algorithms, or any technology related to AI or ML.
No.
The device is an orthopedic plate and fastener system used for the fixation of fractures and osteotomies, which is a surgical intervention rather than a therapeutic device in the sense of delivering therapy (e.g., drug, energy, or rehabilitation).
No
Explanation: The device is a system of orthopedic plates and fasteners used for the fixation of fractures and osteotomies, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly details physical orthopedic plates, fasteners, and surgical tools, indicating it is a hardware-based medical device system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of fractures and osteotomies involving the distal radius." This describes a surgical procedure to repair bone, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device consists of "orthopedic plates and fasteners," "pegs," "screws," and "surgical tools." These are all physical implants and instruments used in surgery, not reagents, analyzers, or other components typically associated with IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory testing.
This device is clearly an implantable orthopedic device used in surgical procedures.
N/A
Intended Use / Indications for Use
The Distal Volar Radius Anatomical Plate System is intended for the fixation of fractures and osteotomies involving the distal radius.
Product codes (comma separated list FDA assigned to the subject device)
LXT
Device Description
The modified Distal Volar Radius Anatomical Plate System is a set of orthopedic plates and fasteners supplied in a sterilization tray together with several reusable and disposable tools. The set of orthopedic plates and fasteners provided in the sterilization tray consists of the following implantable devices: • Distal Volar Plates • Distal Dorsal Nail Plate • Pegs • Screws. Included in the sterilization tray are the following re-useable instruments: • Peg drivers • Other standard surgical tools. In addition, the following are non-reusable instruments included in the sterilization tray: • F.A.S.T. Guide Technology Drill Guide; and • Drill bits
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 (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.
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
APR 2 6 2005
K050932 000043
510(k) Summary of Safety and Effectiveness
| General
Provisions | The name of the device is: | |
---|---|---|
Proprietary Name | Common or Usual Name | |
Distal Volar Radius Anatomical Plate System | Plate Fixation Bone | |
Name of | ||
Predicate | ||
Devices | The device is substantially equivalent to: | |
• Distal Volar Radius Plate System (510(k) # K032705 – October 1, 2003) – Hand | ||
Innovations, Inc. | ||
Classification | Class II. | |
Performance | ||
Standards | Performance standards have not been established by the FDA under section 514 of | |
the Food, Drug and Cosmetic Act. | ||
Indications for | ||
Use | The Distal Volar Radius Anatomical Plate System is intended for the fixation of | |
fractures and osteotomies involving the distal radius. | ||
Device | ||
Description | The modified Distal Volar Radius Anatomical Plate System is a set of orthopedic | |
plates and fasteners supplied in a sterilization tray together with several reusable and | ||
disposable tools. The set of orthopedic plates and fasteners provided in the | ||
sterilization tray consists of the following implantable devices: | ||
• Distal Volar Plates | ||
• Distal Dorsal Nail Plate | ||
• Pegs | ||
• Screws. | ||
Included in the sterilization tray are the following re-useable instruments: | ||
• Peg drivers | ||
• Other standard surgical tools. | ||
In addition, the following are non-reusable instruments included in the sterilization | ||
tray: | ||
• F.A.S.T. Guide Technology Drill Guide; and | ||
• Drill bits | ||
Biocompati- | ||
bility | The implantable components of the Distal Volar Radius Anatomical Plate System | |
and instruments do not require biocompatibility testing because the titanium used in | ||
fabrications meets the requirements of ASTM F 136-96. | ||
Summary of | ||
Substantial | ||
Equivalence | The modified Distal Volar Radius Anatomical Plate System is substantially | |
equivalent to the predicate Distal Volar Radius Repair System. The equivalence was | ||
confirmed through pre-clinical testing. |
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three overlapping, curved lines, possibly representing a stylized human figure or a symbol of health and well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 2005
Mr. Ernesto Hernandez COO, Vice President RA/QA Hand Innovations, Inc. 8905 SW Avenue, Suite 220 Miami, Florida 33176
Re: K050932 Trade/Device Name: Distal Volar Radius Anatomical Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LXT Dated: April 13, 2005 Received: April 14, 2005
Dear Mr. Hernandez:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Ernesto Hernandez
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ruleta
Miriam C. Provost, Ph.D. (一 Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): _______________________
Page of of ___
Device Name: Distal Volar Radius Anatomical Plate System
Indications for Use Statement
The Distal Volar Radius Anatomical Plate System is intended for the fixation of fractures and osteotomies involving 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__________________________________________________________________________________________________________________________________________________________
Erich-Thomsen
021012 018. POT ivision of General, Restorative and Neurologics! Devices
Distal Volar Radius Anatomical Plate System Special 510(k) April 13, 2005
KOS0932