← Product Code [LXT](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LXT) · K090374 # STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S (K090374) _DePuy Orthopaedics, Inc. · LXT · Mar 11, 2009 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LXT/K090374 ## Device Facts - **Applicant:** DePuy Orthopaedics, Inc. - **Product Code:** [LXT](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LXT.md) - **Decision Date:** Mar 11, 2009 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Sterile DVR Anatomic Plating System is intended for fixation of fractures and osteotomies of the distal radius. ## Device Story The Sterile DVR Anatomic Plating System consists of bone plates and screws designed for the fixation of distal radius fractures and osteotomies. The system is provided in a sterile configuration to facilitate surgical use. It is intended for use by orthopedic surgeons in a clinical or operating room setting. The device provides mechanical stabilization of bone segments to promote healing. The surgeon selects and implants the appropriate plates and screws to achieve rigid fixation of the fracture site. ## Clinical Evidence Bench testing only. ## Technological Characteristics Metallic bone fixation plates and screws. Sterile configuration. Class II device under 21 CFR 888.3030. ## 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 - DVR Anatomic Plating System ([K050932](/device/K050932.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}------------------------------------------------ MAR 1 1 2009 . K090374 # 510(k) Summary | Submitted by: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, IN 46581
Phone: (305) 269-6386
Fax: (305) 269-6441 | | |------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------| | Contact Person: | Suzana Otaño, Project Manager, Regulatory Affairs | | | Date Prepared: | February 16, 2009 | | | General
Provisions | The name of the device is: | | | | Proprietary Name | Common or Usual Name | | | DVR Anatomic Plating System | Plate, Fixation, Bone | | Name of
Predicate
Devices | The device is substantially equivalent to the currently marketed DePuy
DVR Anatomic Plating System, K050932. | | | Classification | Class II, 21 CFR 888.3030 | | | Performance
Standards | Performance standards have not been established by the FDA under
section 514 of the Food, Drug and Cosmetic Act for these devices. | | | Indications for
Use | The Sterile DVR Anatomic Plating System is intended for fixation of
fractures and osteotomies of the distal radius. | | | Device
Description | The Sterile DVR Anatomic Plating System offers the DVR plating system
of plates and screws in a sterile configuration. | | | Biocompatibility | The Sterile DVR Anatomic Plating System does not require
biocompatibility testing. | | | Summary of
Substantial
Equivalence | The Sterile DVR Anatomic Plating System is substantially equivalent to
the predicate device. Equivalence was confirmed through bench testing. | | ﺴﮧ {1}------------------------------------------------ Image /page/1/Picture/13 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # MAR 1 1 2009 Depuy Orthopaedics, Inc. % Ms. Suzana Otaño Project Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581 Re: K090374 Trade/Device Names: DePuy Sterile DVR Anatomic Plating 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: February 16, 2009 Received: February 17, 2009 Dear Ms. Otaño: 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 - Ms. Suzana Otaño 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ 510(k) Number: # K090374 #### DePuy Sterile DVR Anatomic Plating System Device Name: ## Indications For Use: The DePuy Sterile DVR Anatomic Plating System is intended for fixation of fractures and osteotomies of the distal radius. Prescription Use (Per 21 CFR 801 Subpart D) AND/OR Over-the-Counter (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|--| |--------------------------------------------------------|--| Bivision Sign-Off) Division of General, Restorative, and Neurological Devices Page 1 of 1 510(k) Number_ --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LXT/K090374](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LXT/K090374) **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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