← Product Code [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS) · K133939 # MODIFIED DISTAL RADIUS PLATING SYSTEM (K133939) _Biomet · HRS · Apr 1, 2014 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K133939 ## Device Facts - **Applicant:** Biomet - **Product Code:** [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS.md) - **Decision Date:** Apr 1, 2014 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use The system is intended for fixation of fractures, malunions and osteotomies involving the distal radius. ## Device Story Modified Distal Radius Plating System consists of titanium alloy extra narrow and extra long plates; utilizes non-locking, locking, and variable angle screws made of titanium alloy and CoCr. Device used by orthopedic surgeons in clinical settings for bone fixation, fracture management, and reconstructive surgeries. System provides mechanical stabilization of distal radius fractures, malunions, and osteotomies. Output is physical fixation of bone segments to facilitate healing. ## Clinical Evidence Bench testing only. Testing included axial load construct testing, 4-point bending testing, evaluation of galvanic corrosion potential, and assessment of multidirectional screw capability. ## Technological Characteristics Materials: Titanium alloy and CoCr. Components: Extra narrow and extra long plates, non-locking, locking, and variable angle screws. Mechanical fixation principle. 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 - Distal Volar Radius Plating System ([K112345](/device/K112345.md)) - Distal Volar Radius Plating System ([K050932](/device/K050932.md)) - Distal Volar Radius Plating System ([K060864](/device/K060864.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}------------------------------------------------ ## Section 5 — 510(k) Summary # APR - 1 2014 | Submitted by: | Biomet Trauma
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Phone: (305) 269-6386
Fax:
(305) 269-6400 | |-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Suzana Otaño, Regulatory Affairs Manager | | Date Prepared: | December 20, 2013 | | Proprietary Name: | Modified Distal Radius Plating System | | Common Name: | Plate, Fixation, Bone | | Classification Name
/ Product Code: | Single/multiple component metallic bone fixation appliances and
accessories (21 CFR § 888.3030) / HRS | | Predicate Devices: | The Modified Distal Radius Plating System is substantially equivalent
to currently marketed Distal Volar Radius Plating System (K112345,
K050932, K060864). | | Device Description: | The Modified Distal Radius Plating System consists of Titanium alloy
Extra Narrow and Extra Long family of plates utilizing non-locking,
locking and variable angle screws manufactured from Titanium alloy
and CoCr for bone fixation and the management of fractures and
reconstructive surgeries. | | Indications for Use: | The system is intended for fixation of fractures, malunions and
osteotomies involving the distal radius. | | Technological
Characteristics: | The technological characteristics of the Modified Distal Radius
Plating System are similar to the predicate devices including design,
dimensions and material. | | Summary of
Substantial
Equivalence: | The Modified Distal Radius Plating System is substantially equivalent
to currently marketed devices as demonstrated with pre-clinical
data including axial load construct testing, 4-point bending testing,
evaluation of galvanic corrosion potential and multidirectional screw
capability. No new issues of safety or efficacy have been raised. | {1}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 1, 2014 Biomet Trauma Ms. Suzana Otaño Regulatory Affairs Manager 56 East Bell Drive PO Box 587 Warsaw, Indiana 46581 Re: K133939 Trade/Device Name: Modified Distal Radius Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: January 3, 2014 Received: January 6, 2014 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 {2}------------------------------------------------ #### Page 2 - Ms. Suzana Otaño (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/McdicalDcvices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, ### Lori A. Wiggins - for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ### SECTION 4 - Indications for Use Statement K133939 510(k) Number: #### Modified Distal Radius Plating System Device Name: Indications For Use: The system is intended for fixation of fractures, malunions and osteotomies involving the distal radius. Prescription Use_ X (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) # Elizabet愉👍Frank -S Division of Orthopedic Devices Page 1 of 1 Modified Distal Radius Plating System - Traditional 510(k) Biomet Trauma - Page 46 of 162 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K133939](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K133939) **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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