(42 days)
The Orthofix Volar Distal Radial Plate is intended for the volar fixation of fractures and osteotomies involving the distal radius.
The Volar Distal Radial Plate is an anatomically contoured, Delta-shaped plate intended for volar applications to the distal radius. The Plate features an angled head with two rows of holes for placement of screws and non-threaded pegs that will be placed distally on the radius to secure bone fragments and provide stabilization. If a bone graft is required, framed access to the site is made possible by the triangular opening in the plate that spans from the plate head to the distal portion of the shaft. The shaft of the Plate is placed proximally on the distal radius and it offers a variety of K-wire and screw placement options for secure fixation to the external surface of the bone. The Plate provides the stabilization and fixation necessary in the treatment of distal radius fractures and osteotomies to allow early functional use of the hand.
An acceptance criteria table and details on a study to prove a device meets acceptance criteria are typically found in the "Performance Data" or "Clinical Studies" sections of a 510(k) submission, neither of which are provided in the input text you've supplied.
The provided text ("510(k) Summary of Safety and Effectiveness" for the "Orthofix Volar Distal Radial Plate") focuses on general device information, description, intended use, and substantial equivalence to predicate devices. It does not contain information regarding device performance, acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The requested information is simply not present in this document.
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510(k) Summary of Safety and Effectiveness
Orthofix Volar Distal Radial Plate
510(k) number K042766
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- General Information:
| Proprietary Name | Orthofix Volar Distal Radial Plate |
|---|---|
| Common Name | Bone Plate |
| Regulatory Class | II |
| Device Classification | 87HRS (21 CFR 888.3030) |
| Submitter | Orthofix Inc.1720 Bray Central DriveMcKinney, Texas 75069 USA469-742-2500 |
| Registration number | 2183449 |
| Contact Person | Nicolle L. FerrisRegulatory Affairs SpecialistPhone 469-742-2578Fax 469-742-2556 |
Summary Preparation Date October 1, 2004
2. Description
The Volar Distal Radial Plate is an anatomically contoured, Delta-shaped plate intended for volar applications to the distal radius. The Plate features an angled head with two rows of holes for placement of screws and non-threaded pegs that will be placed distally on the radius to secure bone fragments and provide stabilization. If a bone graft is required, framed access to the site is made possible by the triangular opening in the plate that spans from the plate head to the distal portion of the shaft. The shaft of the Plate is placed proximally on the distal radius and it offers a variety of K-wire and screw placement options for secure fixation to the external surface of the bone. The
Orthofix Inc. Premarket Notification Volar Distal Radial Plate October 1, 2004
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Plate provides the stabilization and fixation necessary in the treatment of distal radius fractures and osteotomies to allow early functional use of the hand.
The instruments that will be available with the Volar Distal Radial Plate and Bone Screws will include manual surgical instruments that will aid the surgeon in the application of the bone plate and insertion of the screws. Some examples of these instruments are pliers, multiple sizes of hex drivers, drill guides, and depth gauge. These instruments are considered by the Agency to be class I devices and exempt from 510(k) requirements.
3. Intended Use
The Orthofix Volar Distal Radial Plate is intended for the volar fixation of fractures and osteotomies involving the distal radius.
4. Predicate Device
The Orthofix Volar Distal Radial Plate is substantially equivalent in design, material, intended use, and function to two commercially available devices. The TriMed, Inc. Volar Bearing Plate, which was originally cleared by FDA under K040112 on March 12, 2004, and the Stryker Universal Distal Radius System which was originally cleared by FDA under K040022 on March 12, 2004.
Orthofix Inc. Premarket Notification Volar Distal Radial Plate
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Image /page/2/Picture/1 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 emblem featuring a stylized eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2004
Ms. Nicole L. Ferris Regulatory Affairs Specialist Orthofix, Inc. 1720 Bray Central Drive McKinney, Texas 75069
Re: K042766 Trade/Device Name: Orthofix Volar Distal Radial Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: October 1, 2004 Received: October 5, 2004
Dear Ms. Ferris:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becasil of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars and ment date of the Medical Device Amendments, or to commence prior to May 20, 1970, the enaomance with the provisions of the Federal Food, Drug, devices that have occh reclassified in assess approval of a premarket approval application (PMA). alla Cosmetic 710-71mar do not request of the general controls provisions of the Act. The 1 ou may, dicierore, market the act include requirements for annual registration, listing of general controls provisions of uactice, 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 If your device is clusified (800 a00 ro) als. Existing major regulations affecting your device can may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous or reants concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a sond regulations administered by other Federal agencies. You must of any I catales and the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Her Stequirements, internally, which as a set and set CFR Part 607); adoling (21 CFR Part 820); and if applicable, the electronic form in the qualis > by belies (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Nicole L. Ferris
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 prematice modicate 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 Macs gacturers, 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,
b. Mark A. Mellaver
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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INDICATION FOR USE STATEMENT
Page _________________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known): Orthofix Volar Distal Radial Plate -------------------------------------------------------------------------------------------------------------------------------------------Device Name: The Orthofix Volar Distal Radial Plate is intended for the Indications for Use: volar fixation of fractures and osteotomies involving the distal radius.
Prescription Use . _ X (Per 21 CFR 801.109) Or
Over-The-Counter (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark H. Milhmer
Division of General, Restorative, and Neurological Devices
510(k) Number K042766
§ 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.