(99 days)
No
The summary describes a mechanical plating system for bone fixation and does not mention any software, image processing, or AI/ML terms.
Yes
The device is intended for "fixation of fractures, malunions and osteotomies involving the distal radius," which describes a therapeutic action to treat medical conditions.
No
Explanation: The document states the system is "intended for fixation of fractures, malunions and osteotomies" and describes it as a "Plating System" for "bone fixation". This indicates it is a surgical implant device, not a diagnostic one.
No
The device description explicitly states it consists of titanium alloy plates and screws, which are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fixation of fractures, malunions and osteotomies involving the distal radius." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "Plating System" consisting of plates and screws made of metal alloys. These are implants used to stabilize bone.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, or disease. This device does not perform any such analysis of specimens.
This device is a surgical implant used for orthopedic fixation.
N/A
Intended Use / Indications for Use
The system is intended for fixation of fractures, malunions and osteotomies involving the distal radius.
Product codes
HRS
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
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Modified Distal Radius Plating System - Traditional 510(k) Biomet Trauma
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