(30 days)
Not Found
No
The description focuses on the mechanical design and materials of a bone plate system for fracture fixation, with no mention of AI or ML capabilities.
No
The device is described as a plate system for the fixation of fractures and osteotomies of the distal radius, which is a structural support device rather than a therapeutic one that treats or cures a disease or condition.
No
The device is described as a plate system for the fixation of fractures and osteotomies, which is a treatment or therapeutic function, not a diagnostic one. It is used to stabilize rather than identify or characterize a medical condition.
No
The device description clearly describes a physical implantable plate system made of titanium or stainless steel, with screws and K-wires, intended for surgical fixation of fractures. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly describes a surgical implant used to fix bone fractures. It is a physical device inserted into the body to provide structural support.
- Intended Use: The intended use is "fixation of fractures and osteotomies involving the distal radius," which is a surgical procedure, not a diagnostic test performed on a specimen.
The device is an implantable orthopedic device.
N/A
Intended Use / Indications for Use
The fixation of fractures and osteotomies involving the distal radius. This single use device is for cementless use only.
Product codes (comma separated list FDA assigned to the subject device)
87 HRS
Device Description
This anatomically contoured plate system offers several sizes and styles of distal heads in either titanium (ASTM F-136) or stainless steel (ASTM F-138). The distal head of the plate contains two rows of two screw holes each that accept 2.7 mm screws. The distal row of screw holes are threaded allowing for fixed angle support of the fracture fragments utilizing the threaded head screws. The proximal row of screw holes has a spherical seat allowing for variability in screw angle. The threaded head screws vary in length from 16mm to 26mm and are fully threaded. K-wires may also be used for stabilization of bone fragments. The device utilizes a press fit intramedullary fixation for the proximal stem when inserted into the radial intramedullary canal while the distal head is secured to the fracture fragment using the above described bone screws.
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
Image /page/0/Picture/0 description: The image shows the logo for Deo Volente Orthopedics. The logo features the letters DVO in a stylized font, with the words "Deo Volente Orthopedics" written below. The text is in a simple, sans-serif font. The image is in black and white.
OCT 8 = 2004
C092437
510(k) Summary of Safety and Effectiveness
| SUMMARY PREPARED: | September 2, 2004 |
|---|---|
| 510(k) SPONSOR/APPLICANT: | Deo Volente Orthopaedics, LLC |
| 345 N. Buffalo St., Warsaw IN 46580 | |
| 510(k) PREPARER and | |
| CONTACT PERSON: | Dina L. Weissman, J.D. |
| P.O. Box 83, Warsaw IN 46581 | |
| Tel/Fax: (574) 267-8828 | |
| Email: DLWeissman@aol.com | |
| TRADE NAME: | |
| COMMON NAME: | |
| CLASSIFICATION: | Dorsal Intramedullary Plate |
| Plate, Fixation, Bone | |
| Class II per 21 CFR § 888.3030 | |
| Single/multiple component metallic bone fixation | |
| appliances and accessories. | |
| DEVICE PRODUCT CODE: | 87 HRS |
| PREDICATE DEVICES: | |
| · Hand Innovations, Distal Radius Fracture Repair System, K032705, cleared 1 Oct 2003 | |
| · Wright Medical Technology, Locon-T Distal Radial Plate System, K994061, cleared 30 Nov 1999 | |
| DEVICE DESCRIPTION: | This anatomically contoured plate system offers several |
| sizes and styles of distal heads in either titanium (ASTM | |
| F-136) or stainless steel (ASTM F-138). | |
| The distal head of the plate contains two rows of two | |
| screw holes each that accept 2.7 mm screws. The distal | |
| row of screw holes are threaded allowing for fixed angle | |
| support of the fracture fragments utilizing the threaded | |
| head screws. The proximal row of screw holes has a | |
| spherical seat allowing for variability in screw angle |
The threaded head screws vary in length from 16mm to 26mm and are fully threaded. K-wires may also be used for stabilization of bone fragments. The device utilizes a press fit intramedullary fixation for the proximal stem when inserted into the radial intramedullary canal while the distal head is secured to the fracture fragment using the above described bone screws.
fixation while still using the threaded head screws.
INTENDED USE: The fixation of fractures and osteotomies involving the distal radius. Single use device for cementless use only.
COMPARISON TO PREDICATES: The Deo Volente Orthopaedics Dorsal Intramedullary Plate is similar to the listed predicate devices in intended use, performance characteristics, materials of construction, manufacturing methods and design.
345 North Burfalo St Varsaw in 46580 977 777 9DVQ r 1x 574 268.1542 ANT 660 it case to
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a circular logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three parallel lines that curve and converge, resembling a stylized human figure.
Public Health Service
OCT 8 - 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Deo Volente Orthopaedics, LLC C/o Dina L. Weissman P.O. Box 83 Warsaw, Indiana 46581
Re: K042437
Trade/Device Name: Dorsal Intramedullary Plate Regulation Number: 21CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: September 2, 2004 Received: September 8, 2004
Dear Ms Weissman:
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.
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Page 2 - Ms Dina L. Weissman
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/dsma/dsmamain.html
Sincerely yours,
Mark A. Milkean
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K042437
Device Name: Dorsal Intramedullary Plate
Indications for Use:
The fixation of fractures and osteotomies involving the distal radius.
This single use device is for cementless use only.
Prescription Use XXXXX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
・
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K042437