← Product Code [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS) · K042766 # ORTHOFIX VOLAR DISTAL RADIAL PLATE (K042766) _Orthofix, Inc. · HRS · Nov 16, 2004 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K042766 ## Device Facts - **Applicant:** Orthofix, Inc. - **Product Code:** [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS.md) - **Decision Date:** Nov 16, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Orthofix Volar Distal Radial Plate is intended for the volar fixation of fractures and osteotomies involving the distal radius. ## Device Story Anatomically contoured, Delta-shaped bone plate for volar application to distal radius; features angled head with two rows of holes for screws and non-threaded pegs; includes triangular opening for bone graft access; shaft provides K-wire and screw placement options. Used by orthopedic surgeons in clinical/OR settings to secure bone fragments and stabilize fractures or osteotomies. Facilitates early functional hand use. Accompanied by manual surgical instruments (pliers, hex drivers, drill guides, depth gauge). ## Clinical Evidence No clinical data provided; substantial equivalence based on design and technological characteristics. ## Technological Characteristics Anatomically contoured, Delta-shaped metallic bone plate. Features angled head with holes for screws and non-threaded pegs. Includes triangular opening for bone graft access. Manual surgical instrumentation provided. No software or electronic components. ## Regulatory 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. ## Predicate Devices - TriMed, Inc. Volar Bearing Plate ([K040112](/device/K040112.md)) - Stryker Universal Distal Radius System ([K040022](/device/K040022.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # 510(k) Summary of Safety and Effectiveness # Orthofix Volar Distal Radial Plate **510(k) number** K042766 - 1. 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 Drive
McKinney, Texas 75069 USA
469-742-2500 | | Registration number | 2183449 | | Contact Person | Nicolle L. Ferris
Regulatory Affairs Specialist
Phone 469-742-2578
Fax 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ 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. {3}------------------------------------------------ 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 {4}------------------------------------------------ ### 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 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K042766](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K042766) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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